Multiple fluid delivery system with multi-use disposable set and features thereof

ABSTRACT

A multi-fluid injector system having a powered injector having a housing enclosing at least one reciprocally operable piston is described. The injector system includes a multi-use disposable set (MUDS) connectable to the powered fluid injector. The MUDS has at least one syringe having a proximal end and a distal end and a plunger reciprocally movable by the at least one piston element within a syringe interior between the proximal end and the distal end; a manifold in fluid communication with the distal end of the at least one syringe; at least one valve in fluid communication with the syringe interior, the at least one valve operable between a filling position for filling the syringe interior with fluid and a delivery position for delivering the fluid from the syringe interior; and at least one connection port in fluid communication with the manifold and the syringe interior when the at least one valve is in the delivery position. The injector system further includes a coupling mechanism for operating the at least one valve between the filling position and the delivery position. Various features of the MUDS assembly and methods of interaction between the injector system and the MUDS assembly are also described.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. application Ser. No.16/713,299, filed Dec. 13, 2019; which is a divisional of U.S.application Ser. No. 15/541,573, filed Jul. 5, 2017, now U.S. Pat. No.10,570,319, issued Dec. 17, 2019; which is a U.S. national stage filingunder 35 U.S.C. § 371 of International Application No.PCT/US2016/012434, filed Jan. 7, 2016; which claims priority to U.S.Provisional Application No. 62/242,090, entitled “AttachmentConfigurations for Syringe and Manifold,” filed Oct. 15, 2015; U.S.Provisional Application No. 62/242,101, entitled “Rotatable Valve forMultiple Use Disposable System,” filed Oct. 15, 2015; and U.S.Provisional Application No. 62/101,752, entitled “Multi-Fluid DeliverySystem and Single-Use Disposable Set Connector Therefor,” filed Jan. 9,2015, the disclosures of each of which are incorporated in theirentirety herein by this reference.

BACKGROUND OF THE DISCLOSURE Field of the Disclosure

This disclosure relates, in general, to the field of multi-fluiddelivery systems and single-use disposable set (SUDS) connectorstherefor, and, more particularly, to multi-fluid delivery systems havinga multi-patient disposable set having a rotatable valve configured fordelivering fluid to a patient using a SUDS connector.

Description of the Related Art

In many medical diagnostic and therapeutic procedures, a medicalpractitioner, such as a physician, injects a patient with one or moremedical fluids. In recent years, a number of medical fluid deliverysystems for pressurized injection of fluids, such as a contrast solution(often referred to simply as “contrast”), a flushing agent, such assaline, and other medical fluids, have been developed for use inprocedures such as angiography, computed tomography (CT), ultrasound,magnetic resonance imaging (MRI), positron emission tomography (PET),and other imaging procedures. In general, these medical fluid deliverysystems are designed to deliver a preset amount of fluid at a presetflow rate.

In some injection procedures, a medical practitioner places a catheteror needle into a vein or artery of the patient. The catheter or needleis connected to either a manual or an automatic fluid injector system byway of tubing and a connector that interfaces with the fluid injectorsystem. Automatic fluid injector systems typically include at least onesyringe connected to at least one fluid injector having, for example, apowered linear piston. The at least one syringe includes, for example, asource of contrast and/or a source of flushing fluid. The medicalpractitioner enters settings into an electronic control system of thefluid injector for a fixed volume of contrast and/or saline and a fixedrate of injection for each. A single-use disposable set (SUDS) connectorand associated tubing is connected to the fluid injector system fordelivering one or more fluids to the patient.

While various manual and automatic fluid delivery systems are known inthe medical field, improved multi-fluid delivery systems adapted for usein medical diagnostic and therapeutic procedures where one or morefluids are supplied to a patient during such procedures continue to bein demand. Additionally, improved SUDS connectors that may be used withmulti-fluid delivery systems for facilitating a delivery of one or morefluids to a patient are also desired in the medical field. The medicalfield continues to demand improved medical devices and systems used tosupply fluids to patients during various medical procedures.

SUMMARY OF THE DISCLOSURE

In view of the foregoing, a need exists for a medical connector assemblyfor connecting a single-use portion of a medical assembly to a multi-useportion of the assembly. Further, there is a need for a fluid deliverysystem for delivery of multiple fluid doses to multiple patients usingone or more multi-dose containers. The assembly should be configured toretain sterility of the fluid path through the single-use and multi-useportions of the assembly and, particularly, should maintain sterility ofportions of the assembly which are reusable. Furthermore, the systemshould be arranged to permit automatic priming, defined as removing airfrom the fluid line, for easier fluid injections.

Therefore, a medical connector configured to address some or all ofthese needs is provided herein. In accordance with one aspect, a medicalconnector may include a fluid inlet port configured for removableengagement with a connection port of a multi-use disposable set (MUDS)to establish a fluid connection therewith, and a waste outlet portconfigured for removable engagement with a waste inlet port of the MUDSto establish a fluid connection therewith. A patient fluid line may beconnected, at a first end, to the fluid inlet port and connected, at asecond end, to the waste outlet port. Fluid flow through the patientfluid line may be unidirectional from the first end to the second end.The patient fluid line may be configured for being reversiblydisconnected from the waste outlet port for delivering a fluid to apatient.

In another aspect, a locking mechanism may be provided for removablysecuring the medical connector to the MUDS. The fluid inlet port mayinclude a shroud surrounding at least a portion of the fluid inlet port.The fluid inlet port may be shaped to prevent connection with the wasteinlet port of the MUDS and wherein the waste outlet port is shaped toprevent connection with the connection port of the MUDS. The second endof the patient fluid line may have a connector configured for removableengagement with the waste outlet port. The medical connector may have aone-way valve configured for unidirectional flow through the fluid inletport into the patient fluid line. Alternatively, a one-way valve may belocated in the patient fluid line. At least one sensing element may beconfigured for interacting with at least one sensor on the MUDS or onthe injector configured for detecting a presence or absence of the atleast one sensing element indicating that the medical connector has beenproperly inserted or installed.

In another aspect, the at least one connection port may be provided on aframe connected to at least one of the plurality of syringes. The atleast one connection port may be in fluid communication with themanifold through a delivery line. Each of the plurality of syringes mayhave a filling line with a spike configured for connection to a bulkfluid source. Each fluid line may be configured for filling thecorresponding syringe interior through a filling port on the distal endof the syringe when the at least one valve is in the filling position.The at least one valve may have a slot for engagement with acorresponding blade on a powered injector that is configured to rotatethe at least one valve between the filling position and the deliveryposition. The blade is designed for self-alignment and reversibleengagement with the slot in a specific configuration by rotation of theblade relative to the slot until the blade seats into the slot when theblade and slot are in the correct rotational position.

In another aspect, a multi-fluid delivery system may include a poweredinjector comprising a housing enclosing a plurality of reciprocallyoperable piston elements. The housing may have a receiving spaceconfigured for removably receiving a plurality of syringes of a MUDS.The receiving space may have a bottom plate and a top plate spaced apartfrom the bottom plate by a rear sidewall such that the plurality ofsyringes of the MUDS are supported axially between the top plate and thebottom plate. At least one guide may be associated with the receivingspace. The at least one guide may narrow in an insertion directiontoward the rear sidewall to guide the MUDS into the receiving space.

In another aspect, a plurality of bulk fluid connectors may beconfigured for connecting the plurality of syringes of the MUDS with atleast one bulk fluid source. The top plate may have a plurality of slotsconfigured for receiving the distal end of at least one of the pluralityof syringes of the MUDS. Each of the plurality of slots may have amating recess for receiving a conical distal end of the at least onesyringe such that the conical distal end engages the mating recess whenthe MUDS is received in the receiving space. The top plate may bemovable between a first position configured for insertion and removal ofthe MUDS within the receiving space and a second position configured forlocking the MUDS within the receiving space by securing the conicaldistal end of the at least one syringe in the corresponding matingrecess. The top plate may have a latch for locking the top plate in thesecond position. In another aspect, the top plate may lock in the secondposition when an access door on the system is closed and optionallylocked; and the top plate may move to the first position when the accessdoor on the system is opened. At least one coupling may be configuredfor engaging at least one valve on at least one of the plurality ofsyringes of the MUDS. The at least one coupling is a rotatable couplinghaving a blade configured for self-alignment with a slot formed on theat least one valve on the MUDS.

The MUDS may include at least one syringe having a proximal end and adistal end spaced apart from the proximal end along a longitudinal axis,and a plunger reciprocally movable within a syringe interior between theproximal end and the distal end. The MUDS may further include a manifoldin fluid communication with the distal end of the at least one syringe.At least one valve may be in fluid communication with the syringeinterior. The at least one valve may be operable between a fillingposition for filling the syringe interior with fluid and a deliveryposition for delivering the fluid from the syringe interior. The MUDSmay have at least one connection port in fluid communication with themanifold and the syringe interior when the at least one valve is in thedelivery position.

In accordance with another aspect, the at least one valve may have avalve head with a slot recessed into the valve head. The slot may beshaped to receive at least a portion of a coupling mechanism forrotating the at least one valve between the filling position and thedelivery position when the coupling mechanism engages the slot of the atleast one valve. The slot may narrow in a direction from a distal end ofthe valve to a proximal end of the valve. The at least one valve may berotatable within a valve receiving cavity at the distal end of thesyringe between the filling position and the delivery position. In thefilling position, the at least one valve may be operable for filling thesyringe interior through a filling port in fluid communication with abulk fluid source and delivering fluid from the syringe interior througha discharge outlet in fluid communication with the manifold. The atleast one connection port may be provided on a frame connected to atleast one of the plurality of syringes. The at least one connection portmay be in fluid communication with the manifold through a delivery line.The at least one connection port may have a waste port in fluidcommunication with a waste reservoir. A filling line may have a spikefor connection to a bulk fluid source. The fluid line may fill thesyringe interior with fluid through the manifold when the at least onevalve is in the filling position.

In accordance with another aspect, a multi-fluid injector system mayinclude a powered injector having a housing enclosing at least onereciprocally operable piston element and MUDS having at least onesyringe with a proximal end and a distal end spaced apart from theproximal end along a longitudinal axis, and a plunger reciprocallymovable by the at least one piston element within a syringe interiorbetween the proximal end and the distal end. A manifold may be in fluidcommunication with the distal end of the at least one syringe. At leastone valve may be in fluid communication with the syringe interior. Theat least one valve may be operable between a filling position forfilling the syringe interior with fluid and a delivery position fordelivering the fluid from the syringe interior. At least one connectionport may be in fluid communication with the manifold and the syringeinterior when the at least one valve is in the delivery position. Acoupling mechanism may be provided for operating the at least one valvebetween the filling position and the delivery position.

In accordance with another aspect, the coupling mechanism may have ablade and the at least one valve may have a slot shaped to receive theblade of the coupling mechanism. When the blade of the couplingmechanism is received within the slot of the at least one valve,rotation of the coupling mechanism may cause the at least one valve torotate. The coupling mechanism may self-align with the at least onevalve to receive the blade of the coupling mechanism within the slot ofthe at least one valve. The coupling mechanism may be spring-loaded tomaintain contact with the at least one valve as the blade of thecoupling mechanism rotates into alignment with the slot of the at leastone valve. When the blade of the coupling mechanism is aligned with theslot of the at least one valve, the blade may be urged into the slotunder a restoring action of an elastically resilient member. A drivemechanism may be provided for operating the coupling mechanism. Thedrive mechanism may rotate the coupling mechanism. The blade may have atleast one inclined surface that is angled relative to a longitudinalaxis of the at least one valve.

In accordance with another aspect, a MUDS may include a plurality ofsyringes, each syringe having a proximal end and a distal end spacedapart from the proximal end along a longitudinal axis, and a plungerreciprocally movable within a syringe interior between the proximal endand the distal end. A manifold may be connected to the distal end ofeach of the plurality of syringes. At least one valve may be associatedwith the manifold. The at least one valve may be operable between afilling position for filling the syringe interior of at least one of theplurality of syringes through the manifold and a delivery position fordelivering fluid from the syringe interior of at least one of theplurality of syringes through the manifold. At least one filling linemay be in fluid communication with the interior and the syringe interiorof at least one of the plurality of syringes when the at least one valveis in the filling position. At least one connection port may be in fluidcommunication with the manifold and the syringe interior of at least oneof the plurality of syringes when the at least one valve is in thedelivery position. The at least one valve may have a valve head with aslot recessed into the valve head. The slot may be shaped to receive atleast a portion of a coupling mechanism for rotating the at least onevalve between the filling position and the delivery position when thecoupling mechanism engages the slot of the at least one valve.

In accordance with various other aspects, the MUDS may be characterizedin accordance with one or more of the following clauses:

Claus 1. A multi-use disposable set (MUDS) comprising: a plurality ofsyringes, each syringe having a proximal end and a distal end spacedapart from the proximal end along a longitudinal axis, and a plungerreciprocally movable within a syringe interior between the proximal endand the distal end; a manifold in fluid communication with the distalend of each of the plurality of syringes; at least one valve in fluidcommunication with the distal end of at least one of the plurality ofsyringes, the at least one valve operable between a filling position forfilling the syringe interior of at least one of the plurality ofsyringes through the manifold and a delivery position for deliveringfluid from the syringe interior of at least one of the plurality ofsyringes through the manifold; and at least one connection port in fluidcommunication with the manifold when the at least one valve is in thedelivery position.

Clause 2. The MUDS of clause 1, wherein the at least one connection portis provided on a frame connected to at least one of the plurality ofsyringes.

Clause 3. The MUDS of clause 1 or 2, wherein the at least one connectionport is in fluid communication with the manifold through a deliveryline.

Clause 4. The MUDS of any of clauses 1-3, further comprising a wasteport in fluid connection with a waste reservoir.

Clause 5. The MUDS of any of clauses 1-4, wherein each of the pluralityof syringes comprises a filling line with a spike configured forconnection to a bulk fluid source, and wherein each fluid line isconfigured for filling the syringe interior through the manifold whenthe at least one valve is in the filling position.

Clause 6. The MUDS of any of clauses 1-5, wherein the at least one valvecomprises a slot for engagement with a blade that rotates the slotbetween the filling position and the delivery position.

Clause 7. A multi-fluid injector system, comprising: a powered injectorcomprising a housing enclosing a plurality of reciprocally operablepiston elements; a receiving space configured for removably receiving aplurality of syringes of a multi-use disposable set (MUDS), thereceiving space comprising a bottom plate and a top plate spaced apartfrom the bottom plate by a rear sidewall such that the plurality ofsyringes of the MUDS are supported axially between the top plate and thebottom plate; and at least one guide associated with the receivingspace, wherein the at least one guide narrows in an insertion directiontoward the rear sidewall to guide the MUDS into the receiving space.

Clause 8. The multi-fluid injector system of clause 7, furthercomprising a plurality of bulk fluid connectors configured forconnecting the MUDS with at least one bulk fluid source.

Clause 9. The multi-fluid injector system of clause 7 or 8, wherein thetop plate defines a plurality of slots configured for receiving at leastone of the plurality of syringes of the MUDS, and wherein each of theplurality of slots defines a mating recess for receiving a conicaldistal end of the at least one syringe such that the conical distal endengages the mating recess when the MUDS is received in the receivingspace.

Clause 10. The multi-fluid injector system of any of clauses 7-9,wherein the top plate is movable between a first position configured forinsertion and removal of the MUDS within the receiving space and asecond position configured for locking the MUDS within the receivingspace.

Clause 11. The multi-fluid injector system of clause 10, wherein the topplate comprises a latch for locking the top plate in the secondposition.

Clause 12. The multi-fluid injector system of any of clauses 7-11,further comprising at least one coupling configured for engaging atleast one valve on the MUDS.

Clause 13. The multi-fluid injector system of clause 12, wherein the atleast one coupling is a rotatable coupling having a blade configured forself-alignment with a slot formed on the at least one valve on the MUDS.

Clause 14. A MUDS comprising: at least one syringe having a proximal endand a distal end spaced apart from the proximal end along a longitudinalaxis, and a plunger reciprocally movable within a syringe interiorbetween the proximal end and the distal end; a manifold in fluidcommunication with the distal end of the at least one syringe; at leastone valve in fluid communication with the syringe interior, the at leastone valve operable between a filling position for filling the syringeinterior with fluid and a delivery position for delivering the fluidfrom the syringe interior; and at least one connection port in fluidcommunication with the manifold and the syringe interior when the atleast one valve is in the delivery position.

Clause 15. The MUDS according to clause 14, wherein the at least onevalve has a valve head with a slot recessed into the valve head.

Clause 16. The MUDS according to clause 15, wherein the slot is shapedto receive at least a portion of a coupling mechanism for rotating theat least one valve between the filling position and the deliveryposition when the coupling mechanism engages the slot of the at leastone valve.

Clause 17. The MUDS according to clauses 15 or 16, wherein the slotnarrows in a direction from a distal end of the valve to a proximal endof the valve.

Clause 18. The MUDS according to any of clauses 14-17, wherein the atleast one valve is rotatable within a valve receiving cavity at thedistal end of the syringe between the filling position and the deliveryposition.

Clause 19. The MUDS according to any of clauses 14-18, wherein, in thefilling position, the at least one valve is operable for filling thesyringe interior through a filling port in fluid communication with abulk fluid source and delivering fluid from the syringe interior througha discharge outlet in fluid communication with the manifold.

Clause 20. The MUDS according to any of clauses 14-19, wherein the atleast one connection port is provided on a frame connected to at leastone of the plurality of syringes.

Clause 21. The MUDS according to any of clauses 14-20, wherein the atleast one connection port is in fluid communication with the manifoldthrough a delivery line.

Clause 22. The MUDS according to any of clauses 14-21, wherein the atleast one connection port has a waste port in fluid communication with awaste reservoir.

Clause 23. The MUDS according to any of clauses 14-22, furthercomprising a filling line having a spike for connection to a bulk fluidsource, wherein the fluid line fills the syringe interior with fluidthrough the manifold when the at least one valve is in the fillingposition.

Clause 24. A multi-fluid injector system, comprising: a powered injectorcomprising a housing enclosing at least one reciprocally operable pistonelement; a MUDS connectable to the powered fluid injector, the MUDScomprising: at least one syringe having a proximal end and a distal endspaced apart from the proximal end along a longitudinal axis, and aplunger reciprocally movable by the at least one piston element within asyringe interior between the proximal end and the distal end; a manifoldin fluid communication with the distal end of the at least one syringe;at least one valve in fluid communication with the syringe interior, theat least one valve operable between a filling position for filling thesyringe interior with fluid and a delivery position for delivering thefluid from the syringe interior; and at least one connection port influid communication with the manifold and the syringe interior when theat least one valve is in the delivery position; and a coupling mechanismfor operating the at least one valve between the filling position andthe delivery position.

Clause 25. The multi-fluid injector system according to clause 24,wherein the coupling mechanism comprises a blade and wherein the atleast one valve has a slot shaped to receive the blade of the couplingmechanism.

Clause 26. The multi-fluid injector system according to clause 25,wherein, when the blade of the coupling mechanism is received within theslot of the at least one valve, rotation of the coupling mechanismcauses the at least one valve to rotate.

Clause 27. The multi-fluid injector system according to clauses 25-26,wherein the coupling mechanism self-aligns with the at least one valveto receive the blade of the coupling mechanism within the slot of the atleast one valve.

Clause 28. The multi-fluid injector system according to any of clauses25-27, wherein the coupling mechanism is spring-loaded to maintaincontact with the at least one valve as the blade of the couplingmechanism rotates into alignment with the slot of the at least onevalve.

Clause 29. The multi-fluid injector system according to any of clauses25-28, wherein, when the blade of the coupling mechanism is aligned withthe slot of the at least one valve, the blade is urged into the slotunder a restoring action of an elastically resilient member.

Clause 30. The multi-fluid injector system according to any of clauses24-29, further comprising a drive mechanism for operating the couplingmechanism.

Clause 31. The multi-fluid injector system according to any of clauses24-30, wherein the drive mechanism rotates the coupling mechanism.

Clause 32. The multi-fluid injector system according to any of clauses25-31, wherein the blade has at least one inclined surface that isangled relative to a longitudinal axis of the at least one valve.

Clause 33. A MUDS comprising: a plurality of syringes, each syringehaving a proximal end and a distal end spaced apart from the proximalend along a longitudinal axis, and a plunger reciprocally movable withina syringe interior between the proximal end and the distal end; amanifold connected to the distal end of each of the plurality ofsyringes; the at least one valve associated with the manifold, the atleast one valve operable between a filling position for filling thesyringe interior of at least one of the plurality of syringes throughthe manifold and a delivery position for delivering fluid from thesyringe interior of at least one of the plurality of syringes throughthe manifold; at least one filling line in fluid communication with theinterior and the syringe interior of at least one of the plurality ofsyringes when the at least one valve is in the filling position; and atleast one connection port in fluid communication with the manifold andthe syringe interior of at least one of the plurality of syringes whenthe at least one valve is in the delivery position, wherein the at leastone valve has a valve head with a slot recessed into the valve head,wherein the slot is shaped to receive at least a portion of a couplingmechanism for rotating the at least one valve between the fillingposition and the delivery position when the coupling mechanism engagesthe slot of the at least one valve.

In accordance with various other aspects, the present disclosureprovides for attachment configurations between a syringe fluid port ofat least one syringe and a conduit syringe attachment end of a manifoldconduit of a manifold:

Clause 34. A syringe/manifold configuration comprising at least onesyringe having a conical distal end having a syringe fluid port; and amanifold comprising at least one manifold conduit, wherein the manifoldconduit is in fluid connection with a main fluid channel and a conduitsyringe attachment end, wherein the conduit syringe attachment end is influid communication with the syringe fluid port of the at least onesyringe, wherein the conduit syringe attachment end of the at least onemanifold conduit is in fluid tight connection with the syringe fluidport of the at least one syringe.

Clause 35. The syringe/manifold configuration according to clause 34,wherein the at least one manifold conduit comprises a filling portconfigured for fluid communication with a MUDS fluid line, a dischargeoutlet in fluid communication with the main fluid channel, and a valvereceiving cavity, wherein the discharge outlet and the filling port arein fluid communication with an interior of the at least one syringethrough a valve assembly in a valve receiving cavity.

Clause 36. The syringe/manifold configuration according to clause 35,wherein the valve assembly is operable between a filling position forfilling the syringe interior with fluid and a delivery position fordelivering the fluid from the syringe interior.

Clause 37. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein the conduit syringe attachment end of the atleast one manifold conduit is in fluid tight connection with the syringefluid port by a swivel nut attachment mechanism.

Clause 38. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein the conduit syringe attachment end of the atleast one manifold conduit comprises an overmolded polymer sheath thatforms the fluid tight connection by a solvent bond with an inner surfaceof the syringe fluid port.

Clause 39. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein the syringe fluid port comprises an overmoldedpolymer sheath that forms the fluid tight connection by a solvent bondwith an inner surface of the conduit syringe attachment end of the atleast one manifold conduit.

Clause 40. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein an inner surface of the syringe fluid port andthe inner surface of the conduit syringe attachment end each comprise alocking flange extending radially inward and the valve assemblycomprises a syringe locking groove and a manifold locking grooveconfigured to form locking engagements with the locking flanges of thesyringe fluid port and the conduit syringe attachment end, respectively.

Clause 41. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein an outer circumferential surface of theconduit syringe attachment end is bonded to an inner circumferentialsurface of the syringe fluid port by a UV activated adhesive, andwherein the syringe fill port comprises a plurality of lateral slots toallow for expansion of the UV activated adhesive during a curingprocess.

Clause 42 provides: The syringe/manifold configuration according to anyof clauses 34 to 36, wherein an outer circumferential surface of thesyringe fluid port is bonded to an inner circumferential surface of theconduit syringe attachment end by a UV activated adhesive, and whereinthe conduit syringe attachment end comprises a plurality of lateralslots to allow for expansion of the UV activated adhesive during acuring process.

Clause 43. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein the conical distal end of the syringecomprises a plurality of distally facing flexible clips configured toengage a radial flange on an outer circumference of the conduit syringeattachment end.

Clause 44. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein the syringe fluid port includes a longitudinalslot and the conduit syringe attachment end comprises a radial flange,wherein the conduit syringe attachment end is inserted into the syringefluid port where the radial flange is immediately proximal to thelongitudinal slot, and wherein connection between the conduit syringeattachment end and the syringe fluid port is maintained by a C-clipinserted into the longitudinal slot.

Clause 45. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein one of the syringe fluid port and the conduitsyringe attachment end comprises a radial flange and the other of thesyringe fluid port and the conduit syringe attachment end comprises acomplementary radial receiving flange that receives the radial flange,and wherein the radial flange and the complementary radial receivingflange are connected by a laser weld.

Clause 46. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein one of the syringe fluid port and the conduitsyringe attachment end comprises a circumferential receiving slotincluding an energy director and the other of the syringe fluid port andthe conduit syringe attachment end comprises a terminal portion thatengages and is received in the circumferential receiving slot, andwherein the terminal portion and the circumferential receiving slot areconnected by an ultrasonic weld.

Clause 47. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein the syringe fluid port comprises a female luerconnector which forms the fluid tight connection with a male luerconnection on the conduit syringe attachment end, wherein the syringefluid port further comprises a distal circumferential slot between thesyringe fluid port and the conduit syringe attachment end configured forreceiving a UV activated adhesive.

Clause 48. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein engagement between the syringe fluid port andthe conduit syringe attachment end defines a tubular space between aninner surface of the syringe fluid port and an outer surface of theconduit syringe attachment end, wherein the tubular space is configuredfor receiving a UV activated adhesive.

Clause 49. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein engagement between the syringe fluid port andthe conduit syringe attachment end defines a tubular space between aninner surface of the conduit syringe attachment end and an outer surfaceof the syringe fluid port, wherein the tubular space is configured forreceiving a UV activated adhesive.

Clause 50. The syringe/manifold configuration according to any ofclauses 34 to 36, wherein the syringe fluid port comprises a female luerconnector which forms the fluid tight connection with a male luerconnection on the conduit syringe attachment end, wherein the syringefluid port is welded to the conduit syringe attachment end by a lasertack weld.

These and other features and characteristics of multi-fluid deliverysystems and SUDS connectors therefor, as well as the methods ofoperation and functions of the related elements of structures and thecombination of parts and economies of manufacture, will become moreapparent upon consideration of the following description and theappended claims with reference to the accompanying drawings, all ofwhich form a part of this specification, wherein like reference numeralsdesignate corresponding parts in the various figures. It is to beexpressly understood, however, that the drawings are for the purpose ofillustration and description only, and are not intended as a definitionof the limits of the disclosure. As used in the specification and theclaims, the singular form of “a”, “an”, and “the” include pluralreferents unless the context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a multi-fluid delivery system,according to one aspect of the present disclosure;

FIG. 1B is a perspective view of the multi-fluid delivery system of FIG.1A with an access panel in an open position;

FIG. 2 is schematic view of various fluid paths within the multi-fluiddelivery system of FIG. 1A;

FIG. 3A is a perspective view of a MUDS as it is being inserted into areceiving slot on a multi-fluid delivery system;

FIG. 3B is a side view of the MUDS of FIG. 3A;

FIG. 4A is a perspective view of the MUDS installed into a receivingslot on the multi-fluid delivery system of FIG. 3A;

FIG. 4B is a side view of the MUDS of FIG. 4A;

FIG. 4C is a front view of the MUDS of FIG. 4A;

FIG. 5A is a side view of the MUDS prior to removal from the receivingslot on the multi-fluid delivery system of FIG. 3A;

FIG. 5B is a side view of the MUDS after removal from the receiving sloton the multi-fluid delivery system of FIG. 3A;

FIG. 6 is a perspective view of a stopcock coupling on a multi-fluiddelivery system prior to engagement with a stopcock on a MUDS;

FIG. 7A is a side cross-sectional view of the stopcock coupling prior toengagement with the stopcock shown in FIG. 6 ;

FIG. 7B is a side cross-sectional view of the stopcock coupling duringinitial engagement with the stopcock shown in FIG. 6 ;

FIG. 7C is a side cross-sectional view of the stopcock coupling duringfinal engagement with the stopcock shown in FIG. 6 ;

FIG. 8A is a perspective view of a connection interface prior toconnecting a SUDS connector with a multi-fluid delivery system;

FIG. 8B is a perspective view of the connection interface of FIG. 8Ashowing the SUDS connector connected with the multi-fluid deliverysystem;

FIG. 9A is a perspective view of a SUDS connector in accordance with oneaspect;

FIG. 9B is a cross-sectional view of the SUDS connector shown in FIG.9A;

FIG. 9C is a cross-sectional view of the SUDS connector shown in FIG. 9Aconnected to a port of a multi-fluid delivery system;

FIG. 10A is a side view of a MUDS in accordance with another aspect ofthe present disclosure;

FIG. 10B is a top view of the MUDS shown in FIG. 10A;

FIG. 10C is a cross-sectional side view of a syringe for use with theMUDS shown in FIG. 10A;

FIG. 10D is a side perspective view of a MUDS in accordance with anotheraspect of the present disclosure;

FIG. 11 is a cross-sectional side view of a single syringe of the MUDS;

FIG. 12A is a perspective view of a valve for use with the MUDS inaccordance with another aspect of the present disclosure;

FIG. 12B is a side view of the valve shown in FIG. 12A;

FIG. 12C is a cross-sectional side view of the valve shown in FIG. 12Btaken along line A-A;

FIGS. 13A-C illustrate aspects of a syringe/manifold connectionconfiguration;

FIGS. 14A and 14B illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 15A and 15B illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 16A-C illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 17A-C illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 18A-C illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 19A-D illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 20A and 20B illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 21A and 21B illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 22A and 22B illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 23A and 23B illustrate an aspect of a syringe/manifold connectionconfiguration;

FIGS. 24A and 24B illustrate an aspect of a syringe/manifold connectionconfiguration;

FIG. 25A is a perspective view of the SUDS connector shown in FIG. 9Cwith a portion of the multi-fluid delivery system and the MUDS cut away;

FIG. 25B is a detailed perspective view of a sensor rib of the SUDSconnector shown in FIG. 25A;

FIG. 26 is a perspective view of a SUDS connector in accordance withanother aspect;

FIG. 27A is an enlarged cross-sectional view of the SUDS connector shownin FIG. 26 , taken along line A-A;

FIG. 27B is an enlarged cross-sectional view of the SUDS connector shownin FIG. 26 , taken along line B-B;

FIGS. 28A-28F are perspective views of various stages of connecting aSUDS connector to a MUDS connector;

FIG. 29 is a perspective view of a SUDS connector in accordance withanother aspect;

FIG. 30A is a perspective view of a port of a MUDS connector inaccordance with one aspect;

FIG. 30B is a schematic drawing of a cross-sectional view of the MUDSconnector of FIG. 30A;

FIG. 30C is a schematic drawing of a MUDS connector having an absorbentpad attached thereto, according to another aspect;

FIG. 31A is a perspective view of a SUDS connector in accordance withanother aspect;

FIG. 31B is a perspective view of a MUDS connector in accordance withanother aspect;

FIG. 31C is a cross-sectional view of a medical connector assembly, withthe SUDS connector of FIG. 31A inserted to the MUDS connector of FIG.31B;

FIG. 32 is a front perspective view of a SUDS connector in accordancewith another aspect;

FIG. 33A is a perspective view of a SUDS connector in accordance withanother aspect;

FIG. 33B is a cross-sectional view of a medical connection assemblyincluding the SUDS connector of FIG. 33A;

FIG. 34A is a perspective view of a SUDS connector in accordance withanother aspect;

FIG. 34B is a perspective view of a SUDS connector in accordance withanother aspect;

FIG. 35A is a perspective view of a SUDS connector in accordance withanother aspect;

FIG. 35B is a perspective view of a SUDS connector in accordance withanother aspect;

FIG. 36A is a side view of an external clip of the SUDS connector ofFIG. 35A;

FIG. 36B is a perspective view of a SUDS of a medical connectorassembly, according to another aspect; and

FIG. 37 is a schematic view of an electronic control system of amulti-fluid fluid injection system in accordance with another aspect.

DETAILED DESCRIPTION

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the disclosureas it is oriented in the drawing figures. When used in relation to asyringe of a MUDS, the term “proximal” refers to a portion of a syringenearest a piston element for delivering fluid from a syringe. When usedin relation to a SUDS connector, the term “proximal” refers to a portionof a SUDS connector nearest to a multi-fluid injector system when a SUDSconnector is oriented for connecting with a multi-fluid injector system.When used in relation to a syringe of a MUDS, the term “distal” refersto a portion of a syringe nearest to a delivery nozzle. When used inrelation to a SUDS connector, the term “distal” refers to a portion of aSUDS connector nearest to a user when a SUDS connector is oriented forconnecting with a multi-fluid injector system. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, aresimply exemplary aspects of the disclosure. Hence, specific dimensionsand other physical characteristics related to the aspects disclosedherein are not to be considered as limiting.

Referring to the drawings in which like reference characters refer tolike parts throughout the several views thereof, the present disclosureis generally directed to a multi-fluid medical injector/injection system100 (hereinafter “fluid injector system 100”) having a MUDS 130 (shownin FIG. 1B) configured for delivering fluid to a patient using a SUDS190 (shown in FIG. 8A). The fluid injector system 100 includes multiplecomponents as individually described herein. Generally, the fluidinjector system 100 has a powered injector administrator or device and afluid delivery set intended to be associated with the injector todeliver one or more fluids from one or more multi-dose containers underpressure into a patient, as described herein. The various devices,components, and features of the fluid injector system 100 and the fluiddelivery set associated therewith are likewise described in detailherein.

With reference to FIG. 1A, the fluid injector system 100 includes aninjector housing 102 having opposed lateral sides 104, a distal or upperend 106, and a proximal or lower end 108. In some aspects, the housing102 may be supported on a base 110 having one or more wheels 112 forrotatable and movable support of the housing 102 on a floor surface. Theone or more wheels 112 may be lockable to prevent the housing 102 frominadvertently moving once positioned at a desired location. At least onehandle 114 may be provided to facilitate moving and positioning thefluid injector system 100. In other aspects, the housing 102 may beremovably or non-removably secured to a fixed surface, such as a floor,ceiling, wall, or other structure. The housing 102 encloses the variousmechanical drive components, electrical and power components necessaryto drive the mechanical drive components, and control components, suchas electronic memory and electronic control devices (hereinafterelectronic control device(s)), used to control operation of reciprocallymovable piston elements 103 (shown in FIG. 2 ) associated with the fluidinjector system 100 described herein. Such piston elements 103 may bereciprocally operable via electro-mechanical drive components such as aball screw shaft driven by a motor, a voice coil actuator, arack-and-pinion gear drive, a linear motor, and the like. In someaspects, at least some of the mechanical drive components, electricaland power components, and control components may be provided on the base110.

With reference to FIG. 1B, and with continued reference to FIG. 1A, thefluid injector system 100 has at least one door 116 that encloses atleast some of the mechanical drive components, electrical and powercomponents, and control components. The door 116 is desirably movablebetween an open position (shown in FIG. 1B) and a closed position (shownin FIG. 1A). In some aspects, the door 116 may be lockable.

The fluid injector system 100 further includes at least one bulk fluidconnector 118 for connection with at least one bulk fluid source 120. Insome aspects, a plurality of bulk fluid connectors 118 may be provided.For example, as shown in FIGS. 1A and 1B, three bulk fluid connectors118 may be provided in a side-by-side or other arrangement. In someaspects, the at least one bulk fluid connector 118 may be a spikeconfigured for removably connecting to the at least one bulk fluidsource 120, such as a vial, a bottle, or a bag. The at least one bulkfluid connector 118 may have a reusable or non-reusable interface witheach new bulk fluid source 120. The at least one bulk fluid connector118 may be formed on the multi-patient disposable set, as describedherein. The at least one bulk fluid source 120 may be configured forreceiving a medical fluid, such as saline, contrast solution, or othermedical fluid, for delivery to the fluid injector system 100. Thehousing 102 may have at least one support member 122 for supporting theat least one bulk fluid source 120 once it is connected to the fluidinjector system 100.

With reference to FIG. 1A, the fluid injector system 100 includes one ormore user interfaces 124, such as a graphical user interface (GUI)display window. The user interface 124 may display information pertinentto a fluid injection procedure involving fluid injector system 100, suchas current flow rate, fluid pressure, and volume remaining in the atleast one bulk fluid source 120 connected to the fluid injector system100 and may be a touch screen GUI that allows an operator to inputcommands and/or data for operation of fluid injector system 100. Whilethe user interface 124 is shown on the injector housing 102, such userinterface 124 may also be in the form of a remote display that is wiredor wirelessly linked to the housing 102 and control and mechanicalelements of fluid injector system 100. In some aspects, the userinterface 124 may be a tablet computer that is detachably connected tothe housing 102 and is in wired or wirelessly linked communication withthe housing 102. Additionally, the fluid injector system 100 and/or userinterface 124 may include at least one control button 126 for tactileoperation by an attendant operator of the fluid injector system 100. Incertain aspects, the at least one control button may be part of akeyboard for inputting commands and/or data by the operator. The atleast one control button 126 may be hard-wired or wirelessly connectedto the electronic control device(s) associated with the fluid injectorsystem 100 to provide direct input to the electronic control device(s).The at least one control button 126 may also be graphically part of theuser interface 124, such as a touch screen. In either arrangement, theat least one control button 126 desirably provides certain individualcontrol features to the attendant operator of the fluid injector system100, such as but not limited to: (1) acknowledging that a multi-patientdisposable set has been loaded or unloaded; (2) locking/unlocking of themulti-patient disposable set; (3) filling/purging of the fluid injectorsystem 100; (4) inputting information and/or data related to the patientand/or injection procedure, and (5) initiating/stopping an injectionprocedure. The user interface 124 and/or any electronic processing unitsassociated with the fluid injector system 100 may be wired or wirelesslyconnected to an operation and/or data storage system such as a hospitalnetwork system.

With reference to FIG. 1B, the fluid injector system includes a MUDS 130that is removably connected to the fluid injector system 100 fordelivering one or more fluids from the one or more bulk fluid sources120 to the patient. The fluid injector system 100 includes at least oneslot or access port 128 for releasably connecting a SUDS to the MUDS130, as described herein. The MUDS 130 may include one or more syringesor pumps 132. In some aspects, the number of syringes 132 may correspondto the number of bulk fluid sources 120. For example, with reference toFIG. 1B, the MUDS 130 has three syringes 132 in a side-by-sidearrangement such that each syringe 132 is fluidly connectable to one ofthe bulk fluid sources 120. Each syringe 132 may be fluidly connectableto one of the bulk fluid sources 120 by a corresponding bulk fluidconnector 118 and an associated MUDS fluid path 134. The MUDS fluid path134 may be formed as a flexible tube with a spike element at itsterminal end that connects to the bulk fluid connector 118. In someaspects, the bulk fluid connector 118 may be provided directly on theMUDS 130.

With reference to FIGS. 2-3A, the MUDS 130 is removably connectable tothe housing 102 of the fluid injector system 100. The MUDS 130 mayinclude a frame 154 for supporting the one or more syringes 132. Thesyringes 132 may be removably or non-removably connected to the frame154. In certain aspects, the at least one syringe 132 may be co-moldedwith the frame 154 or alternatively, adhered or welded to frame 154.With reference to FIG. 3B, each syringe 132 has an elongated,substantially cylindrical syringe body 138 having a front or distal end140 and a rear or proximal end 142. A syringe plunger 144 is disposedwithin the syringe body 138 and is reciprocally movable within thesyringe body 138 due to movement of a piston element associated with thefluid injector system 100. The distal end 140 of the syringe body 138 isgenerally conical-shaped and tapers to an apex or cone point 145 whichis adapted to interface with a corresponding apex curve formed in therecess defined in the fluid injector system 100, as described herein.The syringe apex or cone point 145 is located along a centrallongitudinal axis L of the syringe body 138.

With continued reference to FIG. 3B, each syringe 132 may have a fillingport 147 in fluid communication with the MUDS fluid path 134 for fillinga syringe interior 139 with fluid from a bulk fluid source 120 (shown inFIG. 2 ). Each syringe 132 may further have discharge outlet or conduit146 at the terminal end of the apex or cone point 145. The dischargeoutlet 146 of each syringe 132 is in fluid communication with a manifold148. In some aspects, the manifold 148 may fluidly connect a pluralityof syringes 132. In certain aspects, the manifold 148 may also providesupport for the syringes 132 such that the syringes 132 can be handledas a single, unitary structure. In some aspects, the manifold 148supports the distal end 140 of each syringe 132 while the frame 154supports the proximal end 142 of each syringe 132. In some aspects, theat least a portion of the manifold 148 may be monolithically formed withat least one syringe 132. In other aspects, the manifold 148 may beformed separately from the plurality of syringes 132 and include aplurality of conduits 148 a corresponding to each of the plurality ofsyringes 132, wherein the individual conduits 148 a may be attached oradhered to the individual outlet ports 146 of each of the plurality ofsyringes 132, for example by an appropriate adhesive or welding. Thesyringes 132 may be arranged in a side-by-side orientation, or any otherorientation that retains the relative positioning of the syringes 132.

With reference to FIGS. 10A-10C, the MUDS 130 is illustrated inaccordance with another aspect. The MUDS 130 may include a plurality ofsyringes 132 in a side-by-side, or other arrangement, with each syringe132 being fluidly connectable to one of the bulk fluid sources 120(shown in FIG. 2 ). Each syringe 132 may be in fluid communication withthe manifold 148. The manifold 148 may include a plate-like structurethat extends between the discharge outlets 146 of the syringes 132 suchthat the manifold 148 monolithically connects the syringes 132. Themanifold 148 may have a fluid pathway 149 that is in fluid communicationwith each syringe 132. The fluid pathway 149 may be in fluidcommunication with one or more fluid outlet lines 152 (shown in FIG. 2). A first portion 148 a of the manifold 148 may be monolithicallyformed with each syringe 132, such as by molding, adhesive means, orwelding, while a second portion 148 b (shown in FIG. 11 ) may bepermanently or non-permanently connected to the first portion 148 a. Insome aspects, the first portion 148 a of the manifold 148 may beconnected to the second portion 148 b by welding, adhesive, one or morefasteners, or any other connection means. The combination of the firstportion 148 a and the second portion 148 b may create a fluid pathwithin the manifold that fluidly connects the discharge ports 146 ofeach of the plurality of syringes 132 and the one or more fluid outletlines 152. At least one of the first portion 148 a and the secondportion 148 b may have a channel 151 extending around a circumference ofthe manifold 148 surrounding the discharge outlets 146. The channel 151may be configured for receiving a gasket 153 (shown in FIG. 11 ) forsealing the interface between the first portion 148 a and the secondportion 148 b. With reference to FIGS. 10B-10C, a valve receiving cavity155 may be provided at the terminal end of the apex or cone point 145 ofeach syringe 132. The valve receiving cavity 155 may extend into thesyringe interior 139 in a direction aligned with a longitudinal axis Lof each syringe 132 (shown in FIG. 10C). In some aspects, the valvereceiving cavity 155 is in fluid communication with the syringe interior139, the filling port 147 and the discharge outlet 146. The valvereceiving cavity 155 is configured for receiving a valve 136 (shown inFIG. 11 ). As described herein, at least a portion of the valve 136 maybe rotatable about the longitudinal axis L and within the valvereceiving cavity 155. The valve 136 may be operable between a fillingposition for filling the syringe interior 139 with fluid and a deliveryposition for delivering the fluid from the syringe interior 139. In someaspects, the valve 136 may be rotatable between a first position, wherethe filling port 147 is in fluid communication with the syringe interior139 while the discharge outlet 146 is in fluid isolation from thesyringe interior 139, and a second position, where the discharge outlet146 is in fluid communication with the syringe interior 139 while thefilling port 147 is in fluid isolation from the syringe interior 139.The valve 136 may have a third position where the interior of thesyringe 139 is isolated from both the filling port 147 and the dischargeoutlet 146. In the first position, the valve 136 may be configured forfilling the syringe interior 139 with fluid from a bulk fluid source 120through the MUDS fluid path 134 while preventing fluid from beingdelivered to the manifold 148. In the second position, the valve 136 maybe configured for delivering fluid from the syringe interior 139 to themanifold 148 through the discharge outlet 146 while preventing fluidfrom being delivered through the filling port 147. The valve 136 mayalso be configured for preventing fluid flow through the filling port147 and the discharge outlet 146 such that fluid cannot be deliveredinto or from the syringe interior 139. In some aspects, the valve 136may be rotatable to partially open or partially closed the dischargeoutlet 146 and/or the filling port 147. In various aspects, the valves136 on each syringe 132 may be controlled independently of each other,for example, such that various medical fluids can be delivered into oneor more syringes 132 and/or, simultaneously or sequentially, bedelivered out of one or more other syringes 132. The valves 136 of theplurality of syringes 132 may be controlled, for example, through theelectronic control device(s) associated with the fluid injector system100

With reference to FIG. 10D, the MUDS 130 is illustrated in accordancewith another aspect. The MUDS 130 may include a plurality of syringes132 in a side-by-side, or other arrangement, with each syringe 132 beingfluidly connectable to one of the bulk fluid sources 120 (shown in FIG.2 ). The MUDS 130 may include a frame 154 for supporting the one or moresyringes 132. The syringes 132 may be removably or non-removablyconnected to the frame 154. In some aspects, each syringe may be fluidlyconnectable to one of the bulk fluid sources 120 by way of the bulkfluid connector 118 and the MUDS fluid path 134. The apex or cone point145 of each syringe 132 may have a discharge outlet 146, a filling port147, and a valve receiving cavity 155. The valve receiving cavity 155may extend into the syringe interior in a direction substantiallyparallel with a longitudinal axis L of each syringe 132 (see e.g., FIG.11 ). The discharge outlet 146 and the filling port 147 may extendtoward the syringe interior in a direction substantially perpendicularto the longitudinal axis L of each syringe 132. The discharge outlet 146and the filling port 147 may be arranged opposite to one another aroundan outer circumference of the apex or cone point 145. In some aspects,the valve receiving cavity 155 is in fluid communication with thesyringe interior, the filling port 147 and the discharge outlet 146.

With continued reference to FIG. 10D, the discharge outlet 146 of eachsyringe 132 may be connected to a manifold 148. Each syringe 132 may beformed separately and be independently connectable to the manifold 148.The manifold 148 may be a tubular structure having a one or moreconduits 148 a for connecting to the discharge outlets 146 of thesyringes 132. In some aspects, the conduits 148 a may be removably ornon-removably connected to the discharge outlets 146. For example, eachconduit 148 a may be adhesively connected, laser or ultrasonic vibrationwelded, or permanently and non-removably fastened by one or moremechanical fasteners to the respective discharge outlet 146.Alternatively, each conduit 148 a may be removably connected to therespective discharge outlet 146, such as, for example, an interferencefit, one or more clips, or other mechanical connection means. Themanifold 148 may have a main fluid channel 148 b that is in fluidcommunication with each syringe 132 through the respective conduit 148a. In some aspects, the one or more conduits 148 a are monolithicallyformed with the main fluid channel 148 b. One end of the main fluidchannel 148 b may be in fluid communication with one or more fluidoutlet lines 152 to deliver fluid from the syringes 132 to the patient,as described herein.

The valve receiving cavity 155 is configured for receiving the valve136. As described herein, at least a portion of the valve 136 may berotatable about the longitudinal axis L and within the valve receivingcavity 155. The valve 136 may be operable between a filling position forfilling the syringe interior with fluid and a delivery position fordelivering the fluid from the syringe interior. In some aspects, thevalve 136 may be rotatable between a first position, where the fillingport 147 is in fluid communication with the syringe interior while thedischarge outlet 146 is in fluid isolation from the syringe interior,and a second position, where the discharge outlet 146 is in fluidcommunication with the syringe interior while the filling port 147 is influid isolation from the syringe interior. In the first position, thevalve 136 may be configured for filling the syringe interior with fluidfrom a bulk fluid source 120 through the MUDS fluid path 134 whilepreventing fluid from being delivered to the manifold 148. In the secondposition, the valve 136 may be configured for delivering fluid from thesyringe interior to the manifold 148 through the discharge outlet 146while preventing fluid from being delivered through the filling port147. The valve 136 may also be configured for preventing fluid flowthrough the filling port 147 and the discharge outlet 146 such thatfluid cannot be delivered into or from the syringe interior. In someaspects, the valve 136 may be rotatable to partially open or partiallyclose the discharge outlet 146 and/or the filling port 147. In variousaspects, the valves 136 on each syringe 132 may be controlledindependently of each other such that fluid can be delivered into one ormore syringes 132 while, simultaneously or sequentially, being deliveredout of one or more other syringes 132.

With further reference to FIG. 2 , the MUDS 130 is removably connectableto the housing 102 of the fluid injector system 100. As will beappreciated by one having ordinary skill in the art, it may be desirableto construct at least a portion of the MUDS 130 from a clear medicalgrade plastic in order to facilitate visual verification that a fluidconnection has been established with the fluid injector system 100.Visual verification is also desirable for confirming that no air bubblesare present within various fluid connections. Alternatively, at least aportion of the MUDS 130 and/or door 116 may include windows (not shown)for visualization of the connection between various components. Variousoptical sensors (not shown) may also be provided to detect and verifythe connections. Additionally, various lighting elements (not shown),such as light emitting diodes (LEDs), may be provided to actuate one ormore optical sensors and indicate that a suitable connection has beenestablished between the various components.

With continued reference to FIG. 2 , a schematic view of various fluidpaths of the fluid injector system 100 is provided. The MUDS 130 mayinclude one or more valves 136, such as stopcock valves, for controllingwhich medical fluid or combinations of medical fluids are withdrawn fromthe multi-dose bulk fluid source 120 and/or are delivered to a patientthrough each syringe 132. In some aspects, the one or more valves 136may be provided on the distal end 140 of the plurality of syringes 132or on the manifold 148. The manifold 148 may be in fluid communicationvia valves 136 and/or syringes 132 with a first end of the MUDS fluidpath 134 that connects each syringe 132 to the corresponding bulk fluidsource 120. The opposing second end of the MUDS fluid path 134 may beconnected to the respective bulk fluid connector 118 that is configuredfor fluidly connecting with the bulk fluid source 120. Depending on theposition of the one or more valves 136, fluid may be drawn into the oneor more syringes 132, or it may be delivered from the one or moresyringes 132. In a first position, such as during the filling of thesyringes 132, the one or more valves 136 are oriented such that fluidflows from the bulk fluid source 120 into the desired syringe 132through the MUDS fluid path 134. During the filling procedure, the oneor more valves 136 are positioned such that fluid flow through one ormore fluid outlet lines 152 or manifold 148 is blocked. In a secondposition, such as during a fluid delivery procedure, fluid from one ormore syringes 132 is delivered to the manifold 148 through the one ormore fluid outlet lines 152 or syringe valve outlet ports. During thedelivery procedure, the one or more valves 136 are positioned such thatfluid flow through the MUDS fluid path 134 is blocked. The one or morevalves 136, the MUDS fluid path 134, and/or fluid outlet lines 152 maybe integrated into the manifold 148. The one or more valves 136 may beselectively positioned to the first or second position by manual orautomatic handling. For example, the operator may position the one ormore valves 136 into the desired position for filling or fluid delivery.In other aspects, at least a portion of the fluid injector system 100 isoperable for automatically positioning the one or more valves 136 into adesired position for filling or fluid delivery based on input by theoperator, as described herein. Suitable examples of valve bodystructures are shown in International Application No. PCT/US2012/056355and U.S. Application Publication No. 2014/0228762, each filed Sep. 20,2012, the disclosures of which are incorporated by this reference.

With specific reference to FIG. 3B, the MUDS 130 further includes aframe 154 receiving at least a portion of the proximal end 142 of the atleast one syringe 132. In some aspects, the frame 154 may be shaped toreceive at least a portion of the proximal end 142 of each syringe 132.In some aspects, the fluid outlet line 152 may be connected to the frame154. The frame 154, in some aspects, defines at least a portion of aconnection port 192 for connecting a SUDS to the MUDS 130. The frame 154may have a handle for grasping the MUDS 130 during insertion into andremoval from the fluid injector system 100. In certain aspects, theconnection port 192, may be formed as part of or adhered/welded to theframe 154 to form a single MUDS unit.

With reference to FIG. 2 , in some aspects, the fluid outlet line 152may also be connected to a waste reservoir 156 on the fluid injectorsystem 100. The waste reservoir 156 is desirably separate from thesyringes 132 to prevent contamination. In some aspects, the wastereservoir 156 is configured to receive waste fluid expelled from thesyringes 132 during, for example, a priming operation. The wastereservoir 156 may be removable from the housing 102 in order to disposeof the contents of the waste reservoir 156. In other aspects, the wastereservoir 156 may have a draining port (not shown) for emptying thecontents of the waste reservoir 156 without removing the waste reservoir156 from the housing 102. In some aspects, the waste reservoir 156 isprovided as a separate component from the MUDS 130.

With the foregoing description of the fluid injector system 100 and theMUDS 130 in mind, exemplary loading and unloading of MUDS 130 into areceiving space 158 (shown in FIG. 3A) on the housing 102 will now bedescribed with reference to FIGS. 3A-5B. In the following discussion, itis assumed that the MUDS 130 may be connected to and removed fromconnection with the fluid injector system 100 for use with a single ormultiple patients. Referring initially to FIG. 3A, the receiving space158 has a bottom plate 160 separated from a top plate 162 by a rearsidewall 164. The bottom plate 160 has a plurality of openings 166through which the piston elements 103 of the fluid injector system 100extend to engage the respective plungers 144 of the MUDS 130. At leastone bottom guide 168 is formed on the bottom plate 160 for guiding theframe 154 of the MUDS 130 as the MUDS 130 is loaded into the fluidinjector system 100. In some aspects, the bottom guide 168 may beconfigured as a pair of walls raised relative to the bottom plate 160and narrowing in an insertion direction toward the rear sidewall 164.During insertion, the bottom guide 168 defines a guiding surface thatlocates the frame 154 of the MUDS 130 and guides the frame 154 towardthe rear sidewall 164 of the receiving space 158. In this manner, theMUDS 130 can be aligned into the receiving space 158 even when MUDS 130is initially misaligned with the receiving space 158.

With reference to FIG. 3B, and with continued reference to FIG. 3A, thetop plate 162 is configured to receive the distal end 140 of the atleast one syringe 132. The top plate 162 has one or more syringe slots170 (shown in FIG. 3A) that are shaped to receive at least a portion ofthe distal end 140 of the syringes 132. In some aspects, when the MUDS130 is inserted into the receiving space 158, the syringe slots 170 ofthe top plate 162 may be disposed between the distal end 140 of the atleast one syringe 132 and the manifold 148. The top plate 162 may berotatable about a pivot point P1, shown in FIG. 3B, or it may be movablein a vertical direction relative to the MUDS 130. In a first position,such as during loading of the MUDS 130 into the receiving space 158, thetop plate 162 may be raised such that the apex or cone point 145 of theat least one syringe 132 clears a lower surface of the top plate 162. Insome aspects, the top plate 162 can default to the first position eachtime the MUDS 130 is removed from the receiving space 158, such as by abiasing mechanism. In other aspects, the top plate 162 can be urged tothe first position as the apex or cone point 145 of the at least onesyringe 132 engages the at least one syringe slot 170.

As the MUDS 130 engages the rear sidewall 164, such as shown in FIG. 4A,the MUDS 130 can be locked in the receiving space 158 by moving the topplate 162 to a second position. In the second position, the top plate162 is lowered such that the apex or cone point 145 of the at least onesyringe 132 engages the lower surface of the top plate 162. In someaspects, the top plate 162 can be urged to the second position by abiasing mechanism (not shown). In other aspects, the top plate 162 canbe manually moved to the second position by pivoting the top plate 162in a direction of arrow A shown in FIGS. 4A-4B. The top plate 162 can belocked relative to the MUDS 130 to prevent removal of the MUDS 130 fromthe receiving space 158 by a latch 172. The latch 172 may be operable toprevent the top plate 162 from rotating about the pivot point P1. Thelatch 172 may be an over-center, spring-loaded latch that is pivotableabout a pivot point P2 in a direction of arrow B shown in FIG. 4B. Withreference to FIG. 4C, when the MUDS 130 is locked within the receivingspace 158, the lower surface of the top plate 162 engages the apex orcone point 145 of the at least one syringe 132. In the locked position,the longitudinal axis L of each syringe 132 is aligned with a center ofeach syringe slot 170. Removal of the MUDS 130 from the receiving space158 when the top plate 162 is in the locked position is prevented by theengagement of the lower surface of the top plate 162 with the apex orcone point 145 of the at least one syringe 132. Once locked, the topplate 162 retains the syringes 132 from moving axially during aninjection procedure.

With reference to FIGS. 5A-5B, the MUDS 130 is removed from thereceiving space 158 by unlocking the top plate 162 from the apex or conepoint or conical portion 145 of the at least one syringe 132. In thefollowing discussion, it is assumed that the MUDS 130 may be removedfrom connection with the fluid injector system 100 and discarded asmedical waste. In some aspects, the top plate 162 is unlocked byunlatching the latch 172 through a pivoting movement of the latch 172about the pivot point P2 in a direction of arrow C shown in FIG. 5A. Asthe latch 172 is unlatched, the top plate 162 is pivoted upwardsrelative to the MUDS 130 in a direction of arrow D shown in FIG. 5B. Byunlocking the top plate 162, the top plate 162 can be moved (i.e.,pivoted or raised) relative to the MUDS 130 to allow the apex or conepoint or conical portion 145 of the at least one syringe 132 to clearthe syringe slot 170 (shown in FIG. 3A) of the top plate 162. The MUDS130 can then be extracted in a direction opposite the insertiondirection by moving the MUDS 130 away from the rear sidewall 164 (shownin FIG. 3A).

With reference to FIG. 6 , in some aspects, the MUDS 130 may have one ormore rotatable valves 136 that control fluid flow through the manifold148. The one or more valves 136 may be rotatable between variouspositions to effect fluid filling or delivery. In some aspects, acoupling mechanism 174 may be provided to rotate the one or more valves136 and thereby control the arrangement of the MUDS 130 for fluidfilling or delivery. The coupling mechanism 174 may be in the form of arotatable coupling 176 that engages the at least one rotatable valve136. In some aspects, the rotatable coupling 176 has a blade 178 that isconfigured to engage with a slot 180 on the at least one rotatable valve136. The rotatable coupling 176 may be rotatable using a drive mechanism(not shown) provided on the fluid injector system 100 to rotate coupling176 by up to 360 degrees until the blade 178 engages slot 180. Thecoupling mechanism 174 may include a sensor (not shown) that senses whenblade 178 engages slot 180 and instructs the coupling mechanism 174 tostop rotating coupling 176. According to various aspects, the couplingmechanism 174 is capable of engaging and coupling to the valve 136regardless of the initial orientation of the slot 180. Thus, anyrotational movement of valve 136, for example during manufacture,shipping, or insertion of MUDS 130, may be compensated for. Once theblade 178 of the rotatable coupling 176 engages the slot 180 on the atleast one rotatable valve 136, rotation of the rotatable coupling 176causes a corresponding rotation of the rotatable valve 136. In thismanner, the arrangement of the one or more valves 136 can be switchedbetween a position for filling the one or more syringes 132 (shown inFIG. 3A) and a position for delivering fluid from the one or moresyringes 132.

With reference to FIGS. 12A-12C, the valve 136 has a valve body 250configured for being rotatably received within at least a portion of thevalve receiving cavity 155 (shown in FIG. 11 ). In some aspects, thevalve 136 is configured to be received within the valve receiving cavity155 in a substantially vertical orientation such that the valve 136 caninterface with the coupling mechanism 174 on the injector. The valvebody 250 has a valve stem 252 connected to a valve head 254. The valvestem 252 may be shaped to be received within at least a portion of thevalve receiving cavity 155. The valve head 254 may be monolithicallyformed with the valve stem 252, such as by molding. In some aspects, thevalve head 254 is formed separately from the valve stem 252 and isremovably or non-removably connected to the valve stem 252. The valvestem 252 and the valve head 254 may be formed from same or differentmaterials. In some aspects, the valve stem 252 is formed as asubstantially cylindrical member with the valve head 254 monolithicallyformed with the valve stem 252 such that the valve head 254 extendsradially outward relative to the valve stem 252. In various aspects, thevalve head 254 may be circular, square, rectangular, or shaped to haveany regular or irregular geometric shape having one or more linear orcurvilinear edges. The valve stem 252 and the valve head 254 may bealigned or offset relative to a longitudinal axis 256 of the valve 136.

At least a portion of the valve 136 may be made from an elastomericmaterial to provide sealing against the sidewall of the valve receivingcavity 155. In some aspects, at least a portion of the valve 136 may bemade from biocompatible, non-pyrogenic, latex free, and/or DEHP freematerials. In other aspects, the valve 136 may be made from a materialthat is compatible with various medical fluids including, withoutlimitation, various contrast solutions and saline solutions. In otheraspects, the valve 136 may be configured for various sterilizationtechniques, including, without limitation, electron beam sterilization,gamma sterilization, and/or ethylene oxide sterilization. In otheraspects, the valve 136 may be configured for use over a predeterminedperiod, such as a period of 24 hours, before the syringe 132, along withthe valve 136 must be disposed. In some aspects, the valve 136 may berated for a maximum operating pressure greater than 350 psi. In otheraspects, actuation torque needed to rotate the valve 136 may be lessthan 3 N-m, with a failure torque greater than 2.5 times the actuationtorque. In other aspects, the valve 136 may be configured for rotationat 60 rpm or more. In other aspects, an internal fluid loss of the valve136 may be less than 0.5% of the total requested volume. In otheraspects, the valve 136 may have allowable leakage of less than 0.1 mlfor a 200 ml syringe 132.

With reference to FIG. 12A, the valve head 254 has the slot 180 formedas a recess that extends into the valve head 254. In some aspects, thevalve head 254 may have a plurality of slots. The slot 180 may extendacross at least a portion of an upper surface of the valve head 254. Insome aspects, the slot 180 may be aligned with the longitudinal axis 256of the valve 136 such that the slot 180 extends in a radial directionrelative to the longitudinal axis 256. In other aspects, the slot 180may be offset relative to the longitudinal axis 256 of the valve 136.The slot 180 may have a uniform or non-uniform width along its length.The slot 180 may be surrounded by one or more recesses 258 having one ormore ribs 260 extending between the slot 180 and an outer circumference262 of the valve head 254. The slot 180 may extend at a uniform ornon-uniform depth into the valve head 254 along the length of the slot180. The slot 180 may have a flat bottom, or it may be angled to form av-shape into the valve head 254.

With reference to FIGS. 12C, the valve stem 252 is desirably hollow witha sidewall 264 defining an outer shape of the valve stem 252. The hollowvalve stem 252 has an interior 268 with an open bottom end 266. Thevalve stem 252 has a first side opening 270 extending through thesidewall 264 at a location offset from the bottom end 266. The firstside opening 270 is in fluid communication with the interior 268 of thevalve stem 252. The first side opening 270 may extend through thesidewall 264 in a direction that is perpendicular or oblique relative tothe longitudinal axis 256 of the valve 136. In some aspects, a pluralityof first side openings 270 may be provided. In such aspects, theplurality of first side openings 270 may extend circumferentially aroundan outer circumference of the valve stem 252 and/or axially along thelongitudinal axis 256 of the valve 136.

With reference to FIG. 12C, an insert 272 may be received within theinterior 268 of the valve stem 252. In some aspects, the insert 272 maybe monolithically formed with the valve 136, such as by co-molding theinsert 272 with the valve 136. At least a portion of the insert 272 mayextend into the recess 258 formed on the valve head 254 to preventrotation of the insert 272 relative to the valve stem 252. The insert272 has a hollow body with a circumferential sidewall 274 surrounding aninterior 275 having an open bottom end 276. At least one second sideopening 278 extends through the sidewall 274 of the hollow body of theinsert 272. The second side opening 278 is aligned with the first sideopening 270 of the valve stem 252 such that the first side opening 270and the second side opening 278 are in fluid communication with eachother. In this manner, the first side opening 270 is in fluidcommunication with the interior 275 of the insert 272 by way of anL-shaped fluid path.

Prior to connection with the fluid injector system 100, the one or morevalves 136 may be misaligned relative to the coupling mechanism 174 onthe fluid injector system 100. In order to align the one or more valves136 for rotation with the coupling mechanism 174, the rotatable coupling176 is rotatable into self-alignment with the at least one valve 136. Asthe MUDS 130 (shown in FIG. 3A) is loaded into the receiving space 158of the fluid injector system 100, at least a portion of the valve 136,such as a portion of its outer sidewall 182 (shown in FIG. 7A), engagesat least a portion of the rotatable coupling 176. Referring to FIG. 7A,the blade 178 of the rotatable coupling 176 may have an inclined surface184 that is angled relative to the outer sidewall 182 of the valve 136.Upon contact with the inclined surface 184, the outer sidewall 182 ofthe valve 136 slides along the inclined surface 184 as the MUDS 130 ismoved into the receiving space 158. Valve sidewall 182 may include abeveled, chamfered, or rounded edge 183 on the distal perimeter of thevalve side wall 182 which may facilitate engagement between the inclinedsurface 184 and the valve 136. Such sliding movement causes therotatable coupling 176 to move vertically in a direction of arrow E inFIG. 7A. In some aspects, the rotatable coupling 176 may bespring-loaded, such that, when the blade 178 is moved in the directionof arrow E, for example when the blade 178 is not correctly aligned withslot 180, a restoring force is stored in an elastically-resilient member188. As shown in FIG. 7C, slot 180 may have a lip 181 on one end whichlimits the orientation of the blade 178 to a single orientation forinsertion into slot 180, for example when inclined surface 184 of blade178 is adjacent to the lip 181. When the MUDS 130 is fully inserted intothe receiving space, the blade 178 of the rotatable coupling 176 ispositioned on an upper surface 186 of the valve 136. To align the valve136 with the rotatable coupling 176, the rotatable coupling 176 isrotated relative to the valve 136 until the blade 178 is aligned withthe slot 180. Once aligned, the blade 178 is lowered into the slot 180.The rotatable coupling 176 may then be urged into the slot 180 under therestoring action of the elastically-resilient member 188. The slot 180may have sidewalls that narrow starting from the upper surface 186 tofacilitate the insertion of the blade 178 into the slot 180. Once theblade 178 is inserted into the slot 180, the rotatable coupling 176 canadjust the orientation of the valve 136 for fluid filling or delivery,as described herein. As there is only one correct orientation betweeneach valve 136 and each rotatable coupling 176, an operating system ofthe injector can determine the orientation of each valve 136 anddetermine the correct rotation of each rotatable coupling 176 necessaryfor filling or delivering fluid from each of the plurality of syringes132 of the MUDS 130.

Having generally described the components of the fluid injector system100 and the MUDS 130, the structure and method of use of a SUDS 190 andits interaction with MUDS 130 will now be described.

With reference to FIGS. 8A and 8B, the fluid injector system 100 has aconnection port 192 that is configured to form a releasable fluidconnection with at least a portion of the SUDS 190. In some aspects, theconnection port 192 may be formed on the MUDS 130. The connection port192 may be shielded by at least a portion of the housing 102 of thefluid injector system 100. For example, recessing the connection port192 within the interior of the housing 102 may preserve the sterility ofthe connection port 192 by preventing or limiting a user or patient fromtouching and contaminating the portions of the connection port 192 thatcontact the fluid to be injected to the patient. In some aspects, theconnection port 192 is recessed within an opening 194 formed on thehousing 102 of the fluid injector system 100, or the connection port 192may have a shielding structure (not shown) that surrounds at least aportion of the connection port 192. In other aspects, the connectionport 192 may be formed directly on the housing 102 and connected to theMUDS 130 by a fluid path (not shown). As described herein, the SUDS 190may be connected to the connection port 192, formed on at least aportion of the MUDS 130 and/or the housing 102. Desirably, theconnection between the SUDS 190 and the connection port 192 is areleasable connection to allow the SUDS 190 to be selectivelydisconnected from the connection port 192 (FIG. 8A) and connected to theconnection port 192 (FIG. 8B). In some aspects, the SUDS 190 may bedisconnected from the connection port 192 and disposed after each fluiddelivery procedure and a new SUDS 190 may be connected to the connectionport 192 for a subsequent fluid delivery procedure.

With continued reference to FIGS. 8A and 8B, a waste inlet port 196 maybe provided separately from the connection port 192. The waste inletport 196 is in fluid communication with the waste reservoir 156. In someaspects, the waste reservoir 156 is provided separately from the SUDS190 such that the fluid from the waste inlet port 196 can be deliveredto the waste reservoir 156. At least a portion of the SUDS 190 may bereleasably connected to or associated with the waste inlet port 196 forintroducing waste fluid into the waste reservoir 156 during, forexample, a priming operation that expels air from the SUDS 190. Thewaste reservoir 156 may have a viewing window 198 with indicia 200, suchas graduated markings, that indicate the fill level of the wastereservoir 156.

With reference to FIG. 9A, the SUDS 190 has a fluid inlet port 202 thatis configured for releasable connection with the connection port 192(shown in FIG. 8A). The fluid inlet port 202 receives fluid deliveredfrom the fluid injector system 100. The fluid inlet port 202 isdesirably a hollow, tubular structure, as shown in FIG. 9B. The SUDS 190further has a waste outlet port 204 that is configured for releasableconnection or association with the waste inlet port 196 (shown in FIG.8A). The waste outlet port 204 receives waste fluid and delivers suchwaste fluid to the waste reservoir 156 during, for example, a primingoperation of the SUDS 190. The waste outlet port 204 is desirably ahollow, tubular structure, as shown in FIG. 9B. The waste outlet port204 may be connected to, inserted into, or located in the waste inletport 202 so that the waste fluid may flow through the waste inlet port202 and continue into waste reservoir 156. The fluid inlet port 202 andthe waste outlet port 204 may be spaced apart from each other by aspacer 206. In some aspects, the spacer 206 is dimensioned to positionthe fluid inlet port 202 and the waste outlet port 204 for alignmentwith the connection port 192 and the waste inlet port 196, respectively.It is noted that the SUDS 190 is shown in FIG. 9A in a state afterremoval from packaging (not shown). Prior to use, the SUDS 190 isdesirably packaged in a pre-sterilized, sealed package that protects theSUDS 190 from contamination with air or surface-borne contaminants.Alternatively, the sealed package and SUDS 190 may be sterilized afterpackaging.

The SUDS 190 desirably has an asymmetrical structure, so that the usercan only attach the SUDS 190 to the MUDS 130 in one orientation. In thismanner, the user is prevented from attaching the fluid inlet port 202 tothe waste inlet port 196. In some aspects, a fin 207 may be provided onat least a portion of the SUDS 190 to prevent erroneous insertion of theSUDS 190 in the connection port 192. In certain aspects, the fin 207 maybe formed on the spacer 206 proximate to the waste outlet port 204. Inthis manner, the fin 207 may interfere with the incorrect insertion ofthe SUDS 190 into the connection port 192. Structures and shapes otherthan a fin 207 may be used to prevent erroneous insertion of the SUDS190 into connection port 192,

In some aspects, tubing 208 may be connected at its proximal end 210 tothe fluid inlet port 202. The tubing 208 is configured to deliver fluidreceived from the fluid inlet port 202. The distal end 212 of the tubing208 may have a connector 214 that is configured for connection with thewaste outlet port 204 or a fluid path connected to the patient (notshown). The tubing 208 may be made from a flexible material, such as amedical grade plastic material, that allows the tubing 208 to be coiled.The connector 214 may be a luer-lock connector (either a male luer-lockconnector or a female luer-lock connector depending on the desiredapplication) or other medical connector configuration. In some aspects,the connector 214 may have a one-way valve to prevent backflow of fluid.Alternatively, a one-way valve may be located elsewhere in the SUDS 190between fluid inlet port 202 and connector 214.

With continued reference to FIG. 9A, the SUDS 190 may have a locking tab216 that is configured for selectively locking the SUDS 190 with thefluid injector system 100 depending on the engagement of the locking tab216 with at least a portion of the fluid injector system 100. In someaspects, the locking tab 216 may be a flexible tab that is deflectablebetween an engaged position and a disengaged position by deflecting atleast a portion of the locking tab 216. The locking tab 216 may have apressing surface 218 that, when pressed, causes the locking tab 216 tobe deflected from the engaged position to the disengaged position forinsertion and removal of the SUDS 190 from the fluid injector system100. In some aspects, the locking tab 216 may be configured forreleasable locking engagement with a receiving slot 217 on the MUDS 130(shown in FIG. 9C).

With reference to FIG. 9B, the SUDS 190 may have a first annular skirt224 extending circumferentially around a proximal end 226 of the fluidinlet port 202 and a second annular skirt 220 extendingcircumferentially around a distal end 222 of the fluid inlet port 202.The first and second annular skirts 224, 220 surround the fluid inletport 202 to prevent inadvertent contact and contamination. The firstannular skirt 224 may have one or more recesses 228 (shown in FIG. 9A)extending through a sidewall thereof. The one or more recesses 228 mayprovide a locking interface with a corresponding locking element (notshown) on the fluid injector system 100. The second annular skirt 220may have at least one indentation 230 (shown in FIG. 9A) to facilitategrasping and handling of the SUDS 190. In some aspects, the secondannular skirt 220 may have a textured surface having one or more ribs232 (shown in FIG. 9A) to facilitate gripping and handling of the SUDS190.

With continued reference to FIG. 9B, at least one annular seal 234 maybe provided around the proximal end 226 of the fluid inlet port 202. Theat least one annular seal 234 may seal the fluid inlet port 202 toprevent fluid from leaking through the SUDS 190. The at least oneannular seal 234 may provide a fluid seal between the SUDS 190 and theMUDS 130 when they are fluidly connected with one another to allow fluidto flow from the MUDS 130 to the SUDS 190 without leaking. A one-wayvalve 236 may be provided within a lumen of the fluid inlet port 202 toprevent fluid from flowing in a reverse direction from the SUDS 190 intothe MUDS 130.

With reference to FIG. 9C, the SUDS 190 shown in FIG. 9A is shownconnected to the fluid injector system 100. While FIG. 9C illustratesthe connection port 192 formed on the MUDS 130, in other aspects, theconnection port 192 may be formed on a portion of the housing 102 (shownin FIG. 1 ). The fluid inlet port 202 of the SUDS 190 is connected tothe connection port 192 to establish a fluid path in a direction ofarrow F shown in FIG. 9C. Fluid passing through the fluid inlet port 202flows through the one-way valve 236 and into tubing 208. Any fluid thatmay drip from the interface between the fluid inlet port 202 and theconnection port 192 is collected in the waste reservoir 156. The wastereservoir 156 may be shaped to collect any fluid that may drip from theSUDS 190 when it is removed from the MUDS 130. Additionally, when theSUDS 190 is connected to the connection port 192, the outlet of thewaste outlet port 204 is positioned within the waste inlet port 196 suchthat waste fluid from the tubing 208 may be discharged into the wastereservoir 156. The spacer 206 may define an insertion stop surface todefine the depth of insertion of the SUDS 190 into the connection port192.

FIGS. 13-24 illustrate various connection configurations between theterminal end of the apex or cone point or distal conical end 145 of theone or more syringes 132 and the manifold 148 including at least onemanifold conduit, wherein the manifold conduit 148 a is in fluidconnection with a main fluid channel 148 b and a conduit syringeattachment end, wherein the conduit syringe attachment end is in fluidcommunication with the syringe fluid port of the at least one syringe132. According to these aspects, the at least one manifold conduit 148 acomprises a filling port 147 configured for fluid communication with aMUDS fluid line 134, a discharge outlet 146 in fluid communication withthe main fluid channel 148 b, and a valve receiving cavity 155, whereinthe discharge outlet 146 and the filling port 147 are in fluidcommunication with an interior 139 of the at least one syringe 132through a valve assembly 272 in a valve receiving cavity 155.

With reference to FIGS. 13A-C, one aspect of a syringe/manifoldconnection configuration including a swivel nut connection is shown. Thedistal conical end 1346 of the at least one syringe 132 includes a maleluer tip and a circumferential groove 1390. Circumferential groove 1390is configured to receive an inward radial flange 1385 of threaded swivelnut 1380 including internal threads 1382. Conduit syringe attachment end1372 of manifold conduit 1370 includes a female luer tip configured forfluid tight connection with male luer tip of distal conical end 1346.Internal threads 1382 threadibly interact with complementary threads1375 on the conduit syringe attachment end 1372 of manifold conduit 1370to connect the manifold conduit 1370 with distal conical end 1346.

With reference to FIGS. 14A-B, one aspect of a syringe/manifoldconnection configuration including an overmolded manifold connectionwith solvent bond is shown. The conduit syringe attachment end 1472 ofthe at least one manifold conduit 1470 comprises an overmolded polymersheath 1476 that forms a fluid tight connection by a solvent bondbetween an outer surface of the conduit syringe attachment end 1472 andan inner surface of the syringe fluid port 1446. In certain aspects theat least one syringe and/or manifold conduit 1470 may be made of a firstpolymeric material, such as, for example polycarbonate, and theovermolded polymer sheath 1476 may be made of a second polymericmaterial, such as polyurethane, that may be overmolded on the conduitsyringe attachment end 1472 during manufacture. The polymeric sheath1476 may then be treated with a solvent, such as but not limited tocyclohexanone, methyl ethyl ketone or other suitable solvent, that atleast partially dissolves the second polymeric material, forming asolvent bond with between the two surfaces upon setting. According toanother aspect illustrated in FIGS. 15A and 15B, the syringe fluid port1546 may comprise the overmolded polymer sheath 1576 that has beenovermolded on an outer surface of the syringe fluid port 1546, whichthen forms a fluid tight connection and seal with the inner surface ofthe conduit syringe attachment end 1572 of the at least one manifoldconduit 1570.

With reference to FIGS. 16A-C, one aspect of a syringe/manifoldconnection configuration including a stem lock configuration using thestem of the valve assembly 136 to connect the syringe and manifold isshown. According to this aspect, an inner surface 1649 of the syringefluid port 1646 comprises a locking flange 1685 extending radiallyinward and the inner surface of the conduit syringe attachment end 1672comprises a locking flange 1673 extending radially inward. Valveassembly 136 comprises a syringe locking groove 1695 and a manifoldlocking groove 1690 configured to form locking engagements with thelocking flanges 1685, 1673 of the syringe fluid port 1646 and conduitsyringe attachment end 1672. Certain aspects may further include one ormore o-rings between the valve assembly and one or both of the syringefluid port 1646 and conduit syringe attachment end 1672.

With reference to FIGS. 17A-C, one aspect of a syringe/manifoldconnection configuration including a UV activated adhesive. According tothis aspect, the outer circumferential surface of the conduit syringeattachment end 1772 is bonded to an inner circumferential surface of thesyringe fluid port 1746 by a UV activated adhesive. To accommodate forpotential swelling of the UV activated adhesive during cure, the syringefill port 1746 may comprise a plurality of lateral slots 1790 to allowfor expansion of the UV activated adhesive during the curing process,where excess adhesive may expand through the lateral slots 1790. Inanother aspect (not shown), the conduit syringe attachment end 1772 maycomprise a plurality of lateral slots to allow for expansion of the UVactivated adhesive during the curing process, where excess adhesive mayexpand through the lateral slots.

With reference to FIGS. 18A-C, one aspect of a syringe/manifoldconnection configuration including a plurality of flexible clip elementsis shown. According to one aspect the conical distal end 145 maycomprise a plurality of distally facing flexible clips 1890 configuredto engage a radial flange 1875 on an outer circumference of the conduitsyringe attachment end 1872 of the manifold conduit 1870. The syringefluid port 1846 may include a male luer tip that sealably engages afemale luer tip on the conduit syringe attachment end 1872. In otheraspect (not shown), the flexible clips may be located on the conduitsyringe attachment end 1872 and project proximally to engage acorresponding flange on the syringe fluid port 1846.

With reference to FIGS. 19A-D, one aspect of a syringe/manifoldconnection configuration including a C-clip locking feature is shown.According to this aspect, syringe fluid port 1946 includes alongitudinal slot 1995 and the conduit syringe attachment end 1972comprises a radial flange 1975. The conduit syringe attachment end 1972is inserted into the syringe fluid port 1946 to a point where the radialflange 1975 is immediately proximal to the longitudinal slot 1995.Connection between the conduit syringe attachment end 1972 and thesyringe fluid port 1746 is maintained by a C-clip 1990 inserted intolongitudinal slot 1995 immediately distal to the radial flange. Theconduit syringe attachment end 1972 may further comprise one or moreO-rings 1999 configured to form a fluid tight seal between the conduitsyringe attachment end 1972 and the syringe fluid port 1946.

With reference to FIGS. 20A-B, one aspect of a syringe/manifoldconnection configuration including a laser weld feature is shown.According to this aspect, one of the syringe fluid port 2046 and theconduit syringe attachment end 2072 comprises a radial flange 2085 witha surface configured for laser welding and the other of the syringefluid port 2046 and the conduit syringe attachment end 2072 comprises acomplementary radial receiving flange 2073 that receives the radialflange 2085 and has a complementary surface configured for laserwelding. The radial flange 2085 and the complimentary radial receivingflange 2073 are connected by a laser weld 2086 therebetween.

With reference to FIGS. 21A-B, one aspect of a syringe/manifoldconnection configuration including an ultrasonic weld feature is shown.According to this aspect, one of the syringe fluid port 2146 and theconduit syringe attachment end 2172 comprises a circumferentialreceiving slot 2185 including an energy director 2186 and the other ofthe syringe fluid port 2146 and the conduit syringe attachment end 2172comprises a terminal portion 2175 that engages and is received in thecircumferential receiving slot 2185. The terminal portion 2175 and thecircumferential receiving slog 2185 are connected by an ultrasonic weldtherebetween by exposure to ultrasonic vibrations, which may be directedby energy director 2186.

With reference to FIGS. 22A-B, one aspect of a syringe/manifoldconnection configuration including luer seal with UV adhesive bond isshown. According to this aspect, the syringe fluid port 2246 maycomprise a female luer connector which forms a liquid tight connectionwith a male luer connector on the conduit syringe attachment end 2272.When assembling the luer connection, a distal circumferential slot 2080is formed between the syringe fluid port 2246 and the conduit syringeattachment end 2272. The distal circumferential slot 2080 is configuredfor receiving a UV activated adhesive which forms an adhesive connectionbetween the syringe fluid port 2246 and the conduit syringe attachmentend 2272 upon irradiation with UV radiation. Reversal of the luerconnections between the syringe fluid port 2246 and the conduit syringeattachment end 2272 is also contemplated.

With reference to FIGS. 23A-B, one aspect of a syringe/manifoldconnection configuration including a UV adhesive bond between thesyringe fluid port 2346 and the manifold conduit 2370 is shown.According to this aspect, engagement between the syringe fluid port 2346and the conduit syringe attachment end 2372 defines a tubular space 2380between an inner surface of the syringe fluid port 2346 and an outersurface of the conduit syringe attachment end 2372. When assembling theconnection, a UV activated adhesive is received within the tubular space2380 which forms an adhesive connection between the syringe fluid port2346 and the conduit syringe attachment end 2372 upon irradiation withUV radiation. Reversal of the connections between the syringe fluid port2346 and the conduit syringe attachment end 2372 is also contemplated.

With reference to FIGS. 24A-B, one aspect of a syringe/manifoldconnection configuration including luer seal with a laser tack weld isshown. According to this aspect, the syringe fluid port 2446 maycomprise a female luer connector which forms a liquid tight connectionwith a male luer connector on the conduit syringe attachment end 2472.Upon assembling the luer connection, a laser tack weld 2480 is formed atthe interface between the syringe fluid port 2446 and the conduitsyringe attachment end 2472. Reversal of the luer connections betweenthe syringe fluid port 2246 and the conduit syringe attachment end 2272is also contemplated.

With reference to FIGS. 25A and B, the fluid injector system 100 mayhave a sensor system 238 adapted to identify when the SUDS 190 is influid communication with the MUDS 130. The sensor system 238 may includeat least one sensing element, such as sensor fin 240 on the SUDS 190 anda corresponding sensor 242 on the fluid injector system 100 or MUDS 130.The sensor 242 may be configured to detect the presence and absence ofthe at least one sensor fin 240, or other sensing element. In someaspects, the sensing element, such as the at least one sensor fin 240 isformed on the locking tab 216 of the SUDS 190, such as shown in FIG. 9A.In other aspects, the sensing element, such as the at least one sensorfin 240 may be formed on any portion of the SUDS 190. The sensor 242 maybe an optical sensor that is seated and secured within a respectivemount formed on the housing 102 of the fluid injector system 100. Aswill be appreciated by those versed in the field of powered medicalfluid injectors, the sensor 242 may be electronically coupled to anelectronic control device used to discretely control operation of thefluid injector system, such as the operation of the one or more pistonelements, based, at least in part, on input from the sensor 242. Thesensing element, such as the sensor fin 240 may have one or morereflective surfaces that reflect visible or infrared light to bedetected by the sensor 242. In other aspects, mechanical interactionbetween the sensing element and the sensor 242 may be used.

In some aspects, the SUDS 190 may further include reuse preventionfeatures (not shown). For example, the SUDS 190 may include one or morebreakable, sensor elements, tabs or structures that fold or break whenthe SUDS 190 is removed from the MUDS 130. Absence of these features mayprevent reinsertion and reuse of the SUDS 190 after removal. In thismanner, it can be assured that the SUDS 190 is only used for one fluiddelivery procedure.

Having generally described the components of the fluid injector system100, the MUDS 130, and the SUDS 190, a method of operation of using theSUDS 190 will now be described in detail. In use, a medical technicianor user removes the disposable SUDS 190 from its packaging (not shown)and inserts the fluid inlet port 202 into the connection port 192 on theMUDS 130. As described above, the SUDS 190 must be inserted in thecorrect orientation, such that the fluid inlet port 202 is aligned forconnection with the connection port 192, and the waste outlet port 204is aligned for connection with the waste inlet port 196. The SUDS 190may be secured to the MUDS 130 by inserting the locking tab 216 into thereceiving slot 217 on the MUDS 130. Once the SUDS 190 is securelyconnected to the MUDS 130, for example as sensed by the sensor 242, thefluid injector system 100 (shown in FIGS. 1A and 1B) draws fluid intoone or more of the plurality of syringes 132 of the MUDS 130 andperforms an automatic priming operation for removing air from the MUDS130 and the SUDS 190. During such priming operation, fluid from the MUDS130 is injected through the connection port 192 and into the tubing 208of the SUDS 190. The fluid flows through the tubing 208 and through thewaste outlet port 204 and into the waste reservoir 156. Once theautomatic priming operation is completed, the medical techniciandisconnects the connector 214 from the waste outlet port 204. Theconnector 214 may then be connected to the patient through a catheter,vascular access device, needle, or additional fluid path set tofacilitate fluid delivery to the patient. Once the fluid delivery iscompleted, the SUDS 190 is disconnected from the patient and the MUDS130 by disengaging the locking tab 216 of the SUDS 190 from thereceiving slot 217 on the MUDS 130. The medical technician may thendispose of the SUDS 190. In certain aspects, removing the SUDS 190 fromthe MUDS 130 causes reuse prevention features (not shown) to activate,thereby preventing reinsertion and reuse of the SUDS 190.

With reference to FIG. 26 , a connection interface between the SUDS 190and the MUDS 130 is shown in accordance with another aspect. The MUDS130 has a connection port 192 that may be configured as a hollow,tubular structure having a luer lock connector 24 (either a male luerlock connector or a female luer lock connector depending on the desiredapplication), extending from a distal end of the port 192 into aninterior of the port 192. Accordingly, the proximal opening of the luerlock connector 24 is recessed within the interior of the port 192. Theluer lock connector 24 may include screw threads 30 (shown in FIG. 27B)for securing the MUDS 130 to the SUDS 190. For example, the screwthreads 30 may be positioned on an outer shroud 32 surrounding the luerlock connector 24, as shown in FIGS. 27A and 27B. Screw threads 30 mayalso be positioned on the luer lock connector 24 itself. The luer lockconnector 24 defines a fluid passageway 34 (shown in FIG. 27B) extendingtherethrough, from the proximal end of the connection port 192 to thedistal opening thereof. While the connection port 192 is depicted asincluding a luer lock connector 24, other styles of connectors,including, but not limited to, clip-in connectors, bayonet connectors,press fit connectors, and the like, may be used within the scope of thepresent disclosure. Additionally, in certain aspects, the connector 24for the connection port 192 is desirably a non-standard connector (e.g.a connector with an unusual size or shape) so that connectors producedby third parties cannot be attached.

The MUDS 130 has a waste inlet port 196 (shown in FIG. 26 ) that mayalso be configured as a hollow, tubular structure. The waste inlet port196 includes a tapered distal nozzle 36 attached to a fluid conduit,such as flexible tubing that connects the waste inlet port 196 to thewaste reservoir 156 (shown in FIG. 2 ).

With reference again to FIG. 26 , as described in detail herein, theMUDS 130 is adapted for connecting to the SUDS 190, which is disposed ofafter a single use. It is noted that the SUDS 190 is shown in FIG. 26 ina state after removal from packaging (not shown). Prior to use, the SUDS190 is desirably packaged in a pre-sterilized, sealed package thatprotects the SUDS 190 from contamination with air or surface-bornecontaminants.

The SUDS 190 may have two or more ports, corresponding to the connectionport 192 and waste inlet port 196 of the MUDS 130. For convenience, theports of the SUDS 190 are equivalent to the fluid inlet port 202 and thewaste outlet port 204 of the SUDS 190 described with reference to FIGS.9A-9B. The ports 202, 204 may be provided in an enclosure 42 suitablefor receipt within the housing 20 of the MUDS 130, as shown in FIG. 27B.The enclosure 42 desirably has an asymmetrical structure, so that theuser can only attach the SUDS 190 to the MUDS 130 in one orientationonly. Thus, for example, the user is prevented from attaching theconnection port 192 of the MUDS 130 to the SUDS 190 waste outlet port204. The ports 202, 204 and enclosure 42 of the SUDS 190 may be madefrom a material suitable for medical applications, such as medical gradeplastic. The tubing 208 of the SUDS 190 is connected between theproximal end of the fluid inlet port 202 and the end of the waste outletport 204 through check valves. The tubing 208 may be provided in a woundor coiled configuration for easy packaging and maneuverability.

With reference to FIGS. 27A and 27B, the SUDS 190 fluid inlet port 202is a hollow, tubular structure configured for insertion in theconnection port 192 of the MUDS 130. The SUDS 190 fluid inlet port 202includes a tubular conduit, such as a luer lock connector 44, defining afluid passageway 46 extending from a proximal end of the port 202,located adjacent to the MUDS 130, and the distal end of the port 204,connected to the tubing 208. The luer lock connector 44 is adapted toconnect to the luer lock connector 24 of the MUDS 130. When securelyconnected, the connection port 192 of the MUDS 130 is in fluidcommunication with the fluid inlet port 202 of the SUDS 190. The luerlock connector 44 may include a thumbwheel 52 for securing theconnection port 192 of the MUDS 130 to the SUDS 190 fluid inlet port202. The thumbwheel 52 may be integrally formed with the luer lockconnector 44 or may be a separate structure fixedly connected to theluer lock connector 44 by conventional means. The thumbwheel 52 rotatesthe luer lock connector 44 causing tabs 54, extending therefrom, toengage the corresponding screw threads 30 in the connection port 192.The tubing 208 is connected to the fluid inlet port 202 through anopening 56 on the thumbwheel 52, such that a continuous fluid connectionis established from the MUDS 130 to the tubing 208.

With continued reference to FIGS. 27A and 27B, the SUDS 190 alsoincludes the SUDS 190 waste outlet port 204. The SUDS waste outlet port204 has a fluid passageway 58, defined by a tubular conduit 60,extending between the waste inlet port 196 of the MUDS 130, and thetubing 208. The tubing 208 may not be directly connected to the wasteinlet port 196 of the MUDS 130. Instead, the tubular conduit 60 of theSUDS 190 may separate the tubing 208 from the MUDS 130, thereby ensuringthat the tubing 208 and the connector 214 are isolated from the wasteinlet port 196 of the MUDS 130. The tubular conduit 60 may be recessedfrom the waste inlet port 196 of the MUDS 130 by a portion of thesingle-use connector enclosure 42, to reduce the likelihood ofcontamination. The tubular conduit 60 may also be angled, relative tothe horizontal, to facilitate fluid flow through the SUDS 190 wasteoutlet port 204 and into the waste inlet port 196 of the MUDS 130. Insome aspects, the SUDS 190 may further include reuse prevention features(not shown). For example, the SUDS 190 may include breakable tabs orstructures that fold or break when the SUDS 190 is removed from the MUDS130. In this manner, it can be assured that the SUDS 190 is only usedfor one fluid delivery procedure.

With reference to FIGS. 28A-28F, a method of operation of the aspect ofthe connection assembly between the SUDS 190 and MUDS 130 depicted inFIGS. 26-27B will now be described in detail. In use, a medicaltechnician or user removes the disposable SUDS 190 from its packagingand inserts the SUDS 190 into the corresponding MUDS 130. As describedabove, the SUDS 190 must be inserted in the correct orientation, suchthat the connection port 192 of the MUDS 130 engages the SUDS 190 fluidinlet port 202, and the waste inlet port 196 of the MUDS 130 engages theSUDS 190 waste outlet port 204. As shown in FIG. 28B, the medicaltechnician then rotates the thumbwheel 52 to secure the SUDS 190 to theMUDS 130. Once the SUDS 190 is securely connected to the MUDS 130, thefluid injector system 100 (shown in FIGS. 1A and 1B) draws fluid intoone or more of the plurality of syringes 132 of the MUDS 130 andperforms an automatic priming operation (FIG. 28C) for removing air fromthe MUDS 130 and the SUDS 190. During such priming operation, fluid fromthe MUDS 130 is injected through the connection port 192 and into thetubing 208 of the SUDS 190. The fluid flows through the tubing 208 andthrough the waste outlet port 204 and into the waste reservoir 156. Oncethe automatic priming operation is completed, the medical techniciandisconnects the connector 214 from the waste outlet port 204 (FIG. 28D).The connector 214 may then be connected to the patient through acatheter, vascular access device, or additional fluid path set tofacilitate fluid delivery to the patient (FIG. 28E). Once the fluiddelivery is completed, the user the connector 214 from the patient androtates the thumbwheel 52 to remove the SUDS 190 from the MUDS 130 (FIG.28F). The medical technician may then dispose of the SUDS 190. Incertain aspects, removing the SUDS 190 from the MUDS 130 causes reuseprevention features (not shown), such as tabs extending from a portionof the SUDS 190, to fold or break, preventing reinsertion of the SUDS190.

With reference to FIG. 29 , a further aspect of a connector assemblyhaving a SUDS 190 and a MUDS 130 is illustrated. In this aspect of theassembly, the SUDS 190 includes a cannula port 62 for receiving a needlecannula 129 connected to a connector 214. The cannula 129, used forfluid delivery to a patient, can be inserted into the cannula port 62after being removed from the patient. The cannula port 62 may cover acontaminated end of the cannula 129 during disposal of the cannula 129.In this aspect, the single-use enclosure 42 is desirably long enough sothat the entire length of the needle cannula 129 may be inserted in theenclosure 42 for a safe disposal.

With reference to FIGS. 30A and 30B, a further aspect of a connectorassembly having a SUDS 190 and a MUDS 130 is illustrated. The connectorassembly is provided in a vertical orientation with the connection port192 of the MUDS 130 positioned above the waste inlet port 196. The MUDS130 includes a drip channel 64 extending between the connection port 192and waste inlet port 196. Any fluid leaking from the connection port 192is directed downward through the drip channel 64 by gravity. The dripchannel 64 exits into the waste inlet port 196. Accordingly, any fluidexpelled from the drip channel 64 is directed through the waste inletport 196 and is collected in the waste reservoir 156. Alternatively, theMUDS 130 may be provided with an absorbent material, such as anabsorbent pad 66 shown in FIG. 30C, surrounding a portion of theconnection port 192 and the waste inlet port 196. The absorbent materialis provided to absorb any fluid drips during removal of the SUDS 190 forimproved drip management.

With reference to FIGS. 31A-31C, a further aspect of the connectorassembly having a SUDS 190 and a MUDS 130 having a plurality ofpress-fit connectors is illustrated. As shown in FIG. 31A, the SUDS 190includes a fluid inlet port 202 and waste outlet port 204. The SUDS 190includes disconnection tabs 68, rather than a thumbwheel. The SUDS 190also includes an alignment structure 70 extending from the enclosure 42of the SUDS 190 and is configured for insertion in a corresponding slot72 of the MUDS 130 (shown in FIG. 31B).

As shown in the cross-sectional view depicted in FIG. 31C, the SUDS 190is inserted into and aligned with the MUDS 130 by alignment channels 71.The disconnection tabs 68 are integrally formed with a tubular shroud 74having an inwardly extending flange 76 at one end thereof. The shroud 74surrounds a tubular conduit 80 on the SUDS 190. When the SUDS 190 isinserted into the MUDS 130, the flange 76 forms an interferenceengagement with a corresponding ridge 78 extending from a portion of theconnection port 192 of the MUDS 130. The interference engagement createsa substantially fluid-tight connection between the MUDS 130 and the SUDS190. Pressing the disconnection tabs 68 of the SUDS 190 disengages theflange 76 from the ridge 78 to allow a user to remove the SUDS 190 fromthe MUDS 130. With reference to FIG. 32 , the connection assembly,having a MUDS 130 and SUDS 190 with disconnection tabs 68 describedabove, may also be provided in a vertical configuration.

With reference to FIGS. 33A and 33B, a further aspect of the connectorassembly having a SUDS 190 and a MUDS 130 is illustrated. The MUDS 130includes the connection port 192 and waste inlet port 196, as describedin previous aspects. The connection port 192 includes a co-moldedsealing surface 82 for enhancing the connection between the SUDS 190 andthe MUDS 130. The SUDS 190 includes external alignment surfaces 84,integrally formed with the enclosure 42, for correctly aligning the SUDS190 and the MUDS 130. The alignment surfaces 84 also recess the fluidinlet port 202 and the waste outlet port 204 of the SUDS 190 to reducethe possibility of contamination prior to use.

With reference to FIGS. 34A-36B, various aspects of the tubing 208 areillustrated. For example, the tubing 208 may be wound about a holdingstructure 133, such as a spool or frame member, for ensuring that thetubing 208 does not unwind while being removed from its packaging orwhen the SUDS 190 is being connected to the MUDS 130. With reference toFIG. 36A, the tubing 208 may further include a removable external clip135. The clip 135 connects about the wound tubing 208 to prevent thetubing 208 from unwinding during removal from packaging or auto-priming.With reference to FIG. 36B, in a further aspect, the tubing 208 isprovided with uncoiled portions 137 to keep the tubing 208 away from theSUDS 190. A coiled portion 139 of the tubing 208 hangs below theun-coiled portions 137, when the SUDS 190 is connected to the MUDS 130.

With reference to FIG. 37 , an electronic control device 900 may beassociated with fluid injector system 100 to control the filling anddelivery operations. In some aspects, the electronic control device 900may control the operation of various valves, piston members, and otherelements to effect a desired filling or delivery procedure. For example,the electronic control device 900 may include a variety of discretecomputer-readable media components. For example, this computer-readablemedia may include any media that can be accessed by the electroniccontrol device 900, such as volatile media, non-volatile media,removable media, non-removable media, transitory media, non-transitorymedia, etc. As a further example, this computer-readable media mayinclude computer storage media, such as media implemented in any methodor technology for storage of information, such as computer-readableinstructions, data structures, program modules, or other data; randomaccess memory (RAM), read only memory (ROM), electrically erasableprogrammable read only memory (EEPROM), flash memory, or other memorytechnology; CD-ROM, digital versatile disks (DVDs), or other opticaldisk storage; magnetic cassettes, magnetic tape, magnetic disk storage,or other magnetic storage devices; or any other medium which can be usedto store the desired information and which can be accessed by theelectronic control device 900. Further, this computer-readable media mayinclude communications media, such as computer-readable instructions,data structures, program modules, or other data in a modulated datasignal, such as a carrier wave or other transport mechanism and includeany information delivery media, wired media (such as a wired network anda direct-wired connection), and wireless media (such as acousticsignals, radio frequency signals, optical signals, infrared signals,biometric signals, bar code signals, etc.). Of course, combinations ofany of the above should also be included within the scope ofcomputer-readable media.

The electronic control device 900 further includes a system memory 908with computer storage media in the form of volatile and non-volatilememory, such as ROM and RAM. A basic input/output system (BIOS) withappropriate computer-based routines assists in transferring informationbetween components within the electronic control device 900 and isnormally stored in ROM. The RAM portion of the system memory 908typically contains data and program modules that are immediatelyaccessible to or presently being operated on by the processing unit 904,e.g., an operating system, application programming interfaces,application programs, program modules, program data, and otherinstruction-based computer-readable codes.

With continued reference to FIG. 37 , the electronic control device 900may also include other removable or non-removable, volatile ornon-volatile, transitory or non-transitory computer storage mediaproducts. For example, the electronic control device 900 may include anon-removable memory interface 910 that communicates with and controls ahard disk drive 912, e.g., a non-removable, non-volatile magneticmedium; and a removable, non-volatile memory interface 914 thatcommunicates with and controls a magnetic disk drive unit 916 (whichreads from and writes to a removable, non-volatile magnetic disk 918),an optical disk drive unit 920 (which reads from and writes to aremovable, non-volatile optical disk 922, such as a CD ROM), a UniversalSerial Bus (USB) port 921 for use in connection with a removable memorycard, etc. However, it is envisioned that other removable ornon-removable, volatile or non-volatile computer storage media can beused in the exemplary computing system environment 902, including, butnot limited to, magnetic tape cassettes, DVDs, digital video tape, solidstate RAM, solid state ROM, etc. These various removable ornon-removable, volatile or non-volatile magnetic media are incommunication with the processing unit 904 and other components of theelectronic control device 900 via the system bus 906. The drives andtheir associated computer storage media, discussed above and illustratedin FIG. 37 , provide storage of operating systems, computer-readableinstructions, application programs, data structures, program modules,program data, and other instruction-based, computer-readable code forthe electronic control device 900 (whether duplicative or not of thisinformation and data in the system memory 908).

A user may enter commands, information, and data into the electroniccontrol device 900 through certain attachable or operable input devices,such as the user interface 124 shown in FIG. 1A, via a user inputinterface 928. Of course, a variety of such input devices may beutilized, e.g., a microphone, a trackball, a joystick, a touchpad, atouch-screen, a scanner, etc., including any arrangement thatfacilitates the input of data, and information to the electronic controldevice 900 from an outside source. As discussed, these and other inputdevices are often connected to the processing unit 904 through the userinput interface 928 coupled to the system bus 906, but may be connectedby other interface and bus structures, such as a parallel port, gameport, or a USB. Still further, data and information can be presented orprovided to a user in an intelligible form or format through certainoutput devices, such as a monitor 930 (to visually display thisinformation and data in electronic form), a printer 932 (to physicallydisplay this information and data in print form), a speaker 934 (toaudibly present this information and data in audible form), etc. All ofthese devices are in communication with the electronic control device900 through an output interface 936 coupled to the system bus 906. It isenvisioned that any such peripheral output devices be used to provideinformation and data to the user.

The electronic control device 900 may operate in a network environment938 through the use of a communications device 940, which is integral tothe electronic control device 900 or remote therefrom. Thiscommunications device 940 is operable by and in communication with theother components of the electronic control device 900 through acommunications interface 942. Using such an arrangement, the electroniccontrol device 900 may connect with or otherwise communicate with one ormore remote computers, such as a remote computer 944, which may be apersonal computer, a server, a router, a network personal computer, apeer device, or other common network nodes, and typically includes manyor all of the components described above in connection with theelectronic control device 900. Using appropriate communication devices940, e.g., a modem, a network interface or adapter, etc., the computer944 may operate within and communicate through a local area network(LAN) and a wide area network (WAN), but may also include other networkssuch as a virtual private network (VPN), an office network, anenterprise network, an intranet, the Internet, etc.

As used herein, the electronic control device 900 includes, or isoperable to execute appropriate custom-designed or conventional softwareto perform and implement the processing steps of the method and systemof the present disclosure, thereby forming a specialized and particularcomputing system. Accordingly, the presently-disclosed method and systemmay include one or more electronic control devices 900 or similarcomputing devices having a computer-readable storage medium capable ofstoring computer-readable program code or instructions that cause theprocessing unit 904 to execute, configure, or otherwise implement themethods, processes, and transformational data manipulations discussedhereinafter in connection with the present disclosure. Still further,the electronic control device 900 may be in the form of a personalcomputer, a personal digital assistant, a portable computer, a laptop, apalmtop, a mobile device, a mobile telephone, a server, or any othertype of computing device having the necessary processing hardware toappropriately process data to effectively implement thepresently-disclosed computer-implemented method and system.

It will be apparent to one skilled in the relevant arts that the systemmay utilize databases physically located on one or more computers whichmay or may not be the same as their respective servers. For example,programming software on electronic control device 900 can control adatabase physically stored on a separate processor of the network orotherwise.

In some aspects, the electronic control device 900 may be programmed sothat automatic refill occurs based upon a preprogrammed trigger minimumvolume in the respective syringes 132. For example, when the volume offluid remaining in at least one of the syringes 132 is less than aprogrammed volume, a syringe refill procedure is automatically initiatedby the electronic control device 900. The electronic control device 900associated with the fluid injector system 100 may determine that thepreprogrammed trigger minimum volume has been reached by tracking thefluid volume dispensed from the respective syringes 132 during operationof the fluid injector system 100. Alternatively, fluid level sensors maybe incorporated into the fluid injector system 100 and inputs from thesefluid level sensors may be provided to the electronic control device 900so that the electronic control device 900 may determine when thepreprogrammed trigger minimum volume has been reached in at least one ofthe syringes 132. The fill volume and rate of refill can bepreprogrammed in the electronic control device 900. The automatic refillprocedure can be stopped either automatically by the electronic controldevice 900 or may be manually interrupted. In addition, an automaticrefill procedure may be initiated when, at the completion of a fluidinjection procedure, there is not enough fluid in at least one of thesyringes 132 to perform the next programmed fluid injection procedure.

During a refill procedure it is possible that one or more of the bulkfluid sources 120 associated with the respective syringes 132 may becomeempty, (e.g., initially lack sufficient fluid to complete a full refillof the one or more syringes 132). A replacement bulk fluid source 120is, therefore, necessary and replacement of such bulk fluid source 120is desirably made quickly. The fluid injector system 100 may have anindicator, such as an audible and/or visual indicator, to indicate tothe operator that a change of the bulk fluid source 120 is necessarybefore the fluid injector system 100 may be used.

While several aspects of multi-fluid delivery systems and multi- andSUDS connectors therefor are shown in the accompanying figures anddescribed hereinabove in detail, other aspects will be apparent to, andreadily made by, those skilled in the art without departing from thescope and spirit of the disclosure. For example, it is to be understoodthat this disclosure contemplates that, to the extent possible, one ormore features of any aspect can be combined with one or more features ofany other aspect. Accordingly, the foregoing description is intended tobe illustrative rather than restrictive.

We claim:
 1. A multi-fluid injector system, comprising: a poweredinjector comprising a housing enclosing at least one reciprocallyoperable piston element; a multi-use disposable set (MUDS) connectableto the powered fluid injector, the MUDS comprising: at least one syringehaving a proximal end and a distal end spaced apart from the proximalend along a longitudinal axis, and a plunger reciprocally movable by theat least one piston element within a syringe interior between theproximal end and the distal end; a manifold in fluid communication withthe distal end of the at least one syringe; at least one valve in fluidcommunication with the syringe interior, the at least one valve operablebetween a filling position for filling the syringe interior with fluidand a delivery position for delivering the fluid from the syringeinterior; and at least one connection port in fluid communication withthe manifold and the syringe interior when the at least one valve is inthe delivery position; and a coupling mechanism for operating the atleast one valve between the filling position and the delivery position.2. The multi-fluid injector system of claim 1, wherein the couplingmechanism comprises a blade and wherein the at least one valve has aslot shaped to receive the blade of the coupling mechanism.
 3. Themulti-fluid injector system of claim 2, wherein, when the blade of thecoupling mechanism is received within the slot of the at least onevalve, rotation of the coupling mechanism causes the at least one valveto rotate.
 4. The multi-fluid injector system of claim 2, wherein thecoupling mechanism self-aligns with the at least one valve to receivethe blade of the coupling mechanism within the slot of the at least onevalve.
 5. The multi-fluid injector system of claim 4, wherein thecoupling mechanism is spring-loaded to maintain contact with the atleast one valve as the blade of the coupling mechanism rotates intoalignment with the slot of the at least one valve.
 6. The multi-fluidinjector system of claim 4, wherein, when the blade of the couplingmechanism is aligned with the slot of the at least one valve, the bladeis urged into the slot under a restoring action of an elasticallyresilient member.
 7. The multi-fluid injector system of claim 1, furthercomprising a drive mechanism for operating the coupling mechanism. 8.The multi-fluid injector system of claim 7, wherein the drive mechanismrotates the coupling mechanism.
 9. The multi-fluid injector system ofclaim 1, wherein the blade has at least one inclined surface that isangled relative to a longitudinal axis of the at least one valve.
 10. Asyringe comprising: a proximal end and a distal end spaced apart fromthe proximal end along a longitudinal axis to define a syringe interior;and a rotatable valve in fluid communication with the syringe interior,the rotatable valve rotatably operable between a filling position forfilling the syringe interior with fluid and a delivery position fordelivering the fluid from the syringe interior, wherein the rotatablevalve has a valve head with a recessed slot shaped to receive a couplingmechanism of a powered fluid injector to operate the rotatable valvebetween the filling position and the delivery position.
 11. The syringeof claim 10, wherein the recessed slot receives a blade of the couplingmechanism.
 12. The syringe of claim 11, wherein, when the blade of thecoupling mechanism is received within the recessed slot, rotation of thecoupling mechanism rotates the rotatable valve.
 13. The syringe of claim10, wherein the coupling mechanism is spring-loaded to maintain contactwith the rotatable valve as the coupling mechanism rotates intoalignment with the recessed slot.
 14. The syringe of claim 10, wherein,when the coupling mechanism is aligned with the recessed slot, thecoupling mechanism is urged into the recessed slot under a restoringaction of an elastically resilient member.
 15. A method of aligning arotatable valve at a distal end of a syringe with a coupling mechanismof a fluid injector, the method comprising; inserting the syringe into areceiving space of the fluid injector; forcing a blade of the couplingmechanism in a vertically upward direction to ride over an outersidewall and along a top surface of a valve head of the rotatable valve;rotating the coupling mechanism around a longitudinal axis until theblade is self-aligned with a recessed slot in the valve head; and whenthe blade of the coupling mechanism is self-aligned with the recessedslot of the valve head, urging the blade into the recessed slot under arestoring force of an elastically resilient member associated with theblade.
 16. The method of claim 15, wherein forcing the blade of thecoupling mechanism in a vertically upward direction comprises:contacting an inclined surface of the blade of the coupling mechanismwith an outer sidewall of the valve head, wherein the inclined surfaceof the blade slides along the outer sidewall as the syringe is movedinto the receiving space of the fluid injector; and compressing theelastically resilient member associated with the blade as the blade isforced in a vertically upward direction such that the restoring force isstored in the elastically resilient member.
 17. The method of claim 16,wherein contacting the inclined surface of the blade with the outersidewall of the valve head comprises: contacting the inclined surface ofthe blade with a beveled, chamfered, or rounded edge of a distalperimeter of the outer sidewall of the valve head to facilitateengagement between the inclined surface and the valve head.
 18. Themethod of claim 15, wherein rotating the coupling mechanism around thelongitudinal axis until the blade is self-aligned with the recessed slotin the valve head comprises: rotating the coupling mechanism until anend of the blade having the inclined surface is adjacent to a lip at oneend of the recessed slot.
 19. The method of claim 15, furthercomprising: communicating a position of the valve head relative to afilling position and a delivery position of the rotatable valve to anoperating system of the fluid injector; and determining by the operatingsystem an orientation of the rotatable valve and a correct rotation ofthe rotatable valve to operatively rotate the rotatable valve between afilling position, a delivery position, and a closed position.